Apparatus and method for measuring biologic parameters

ABSTRACT

Support structures for positioning sensors on a physiologic tunnel for measuring physical, chemical and biological parameters of the body and to produce an action according to the measured value of the parameters. The support structure includes a sensor fitted on the support structures using a special geometry for acquiring continuous and undisturbed data on the physiology of the body. Signals are transmitted to a remote station by wireless transmission such as by electromagnetic waves, radio waves, infrared, sound and the like or by being reported locally by audio or visual transmission. The physical and chemical parameters include brain function, metabolic function, hydrodynamic function, hydration status, levels of chemical compounds in the blood, and the like. The support structure includes patches, clips, eyeglasses, head mounted gear and the like, containing passive or active sensors positioned at the end of the tunnel with sensing systems positioned on and accessing a physiologic tunnel.

This application is a continuation of U.S. Ser. No. 10/786,623, filedFeb. 26, 2004, which is a continuation-in-part of U.S. Ser. No.10/420,295, filed Apr. 22, 2003, which claims the benefit of U.S.Provisional Application Ser. No. 60/374,133, filed Apr. 22, 2002, andclaims the benefit of the priority of 60/449,800, filed Feb. 26, 2003,60/475,470, filed Jun. 4, 2003 and 60/497,306, filed Aug. 25, 2003,herein incorporated in their entirety by reference.

FIELD OF THE INVENTION

The present invention includes support and sensing structures positionedin a physiologic tunnel for measuring bodily functions and to manageabnormal conditions indicated by the measurements.

BACKGROUND OF THE INVENTION

Interfering constituents and variables can introduce significant sourceof errors that prevent measured biologic parameters from being ofclinical value. In order to bypass said interfering constituents andachieve undisturbed signals, invasive and semi-invasive techniques havebeen used. Such techniques have many drawbacks including difficulties inproviding continuous monitoring for long periods of time. Non-invasivetechniques also failed to deliver the clinical usefulness needed. Theplacement of a sensor on the skin characterized by the presence ofinterfering constituents do not allow obtaining clinically useful noraccurate signals due to the presence of said interfering constituentsand background noise which greatly exceeds the signal related to thephysiologic parameter being measured.

The most precise, accurate, and clinically useful way of evaluatingthermal status of the body in humans and animals is by measuring braintemperature. Brain temperature measurement is the key and universalindicator of both disease and health equally, and is the only vital signthat cannot be artificially changed by emotional states. The other vitalsigns (heart rate, blood pressure, and respiratory rate) all can beinfluenced and artificially changed by emotional states or voluntaryeffort.

Body temperature is determined by the temperature of blood, which emitsheat as far-infrared radiation. Adipose tissue (fat tissue) absorbsfar-infrared and the body is virtually completely protected with a layerof adipose tissue adherent to the skin. Thus measurement of temperatureusing the skin did not achieve precision nor accuracy because previoustechniques used sensors placed on skin characterized by the presence ofadipose tissue.

Because it appeared to be impossible with current technology tonon-invasively measure brain temperature, attempts were made todetermine internal body temperature, also referred to as coretemperature. An invasive, artificial, inconvenient, and costly processis currently used to measure internal (core) temperature consisting ofinserting a catheter with a temperature sensor in the urinary canal,rectum or esophagus. But such methodology is not suitable for routinemeasurement, it is painful, and has potential fatal complications.

Semi-invasive techniques have also being tried. Abreu disclosed in U.S.Pat. No. 6,120,460 apparatus and methods for measuring core temperaturecontinuously using a contact lens in the eyelid pocket, but the contactlens is a semi-invasive device which requires prescription by aphysician and sometimes it is not easy to place the contact lens in theeye of an infant or even in adults and many people are afraid oftouching their eyes.

There are several drawbacks and limitations in the prior art forcontinuous and/or core measurement of temperature.

Measurement of temperature today is non-continuous, non-core and nursedependent. Nurses have to stick a thermometer in the patient's mouth,rectum or ear. To get core temperature nurses invasively place a tubeinside the body which can cause infection and costly complications.

Measurement of core temperature on a routine basis in the hospitaland/or continuously is very difficult and risky because it requires aninvasive procedure with insertion of tubes inside the body or byingesting a thermometer pill. The thermometer pill can cause diarrhea,measure temperature of the fluid/food ingested and not body temperature,and have fatal complications if the pill obstructs the pancreas or liverducts. Placement of sensors on the skin do not provide clinically usefulmeasurements because of the presence of many interfering constituentsincluding fat tissue.

It is not possible to acquire precise and clinically useful measurementsof not only brain temperature, but also metabolic parameters, physicalparameters, chemical parameters, and the like by simply placing a sensoron the skin. One key element is the presence of fat tissue. Fat variesfrom person to person, fat varies with aging, fat content varies fromtime to time in the same person, fat attenuates a signal coming from ablood vessel, fat absorbs heat, fat prevents delivery of undisturbedfar-infrared radiation, fat increases the distance traveled by theelement being measured inside the body and an external sensor placed onthe surface of the skin.

There is a need to identify a method and apparatus that cannon-invasively, conveniently and continuously monitor brain temperaturein a painless, simple, external and safe manner with sensors placed onthe skin.

There is further a need to identify a method and apparatus that canconveniently, non-invasively, safely and precisely monitor biologicalparameters including metabolic parameters, physical parameters, chemicalparameters, and the like.

There is a need to identify an apparatus and method capable of measuringbiological parameters by positioning a sensor on a physiologic tunnelfor the acquisition of undisturbed and continuous biological signals.

SUMMARY OF THE INVENTION

The present invention provides methods, apparatus and systems thateffectively address the needs of the prior art.

In general, the invention provides a set of sensing systems andreporting means which may be used individually or in combination, whichare designed to access a physiologic tunnel to measure biological,physical and chemical parameters. Anatomically and physiologicallyspeaking, the tunnel discovered by the present invention is an anatomicpath which conveys undisturbed physiologic signals to the exterior. Thetunnel consists of a direct and undisturbed connection between thesource of the function (signal) within the body and an external point atthe end of the tunnel located on the skin. A physiologic tunnel conveyscontinuous and integral data on the physiology of the body. Anundisturbed signal from within the body is delivered to an externalpoint at the end of the tunnel. A sensor placed on the skin at the endof the tunnel allows optimal signal acquisition without interferingconstituents and sources of error.

Included in the present invention are support structures for positioninga sensor on the skin at the end of the tunnel. The present inventiondiscloses devices directed at measuring brain temperature, brainfunction, metabolic function, hydrodynamic function, hydration status,hemodynamic function, body chemistry and the like. The componentsinclude devices and methods for evaluating biological parameters usingpatches, clips, eyeglasses, head mounted gear and the like with sensingsystems adapted to access physiologic tunnels to provide precise andclinically useful information about the physiologic status of the wearerand for enhancing the safety and performance of said wearer, and helpingto enhance and preserve the life of said wearer by providing adequatereporting means and alert means relating to the biological parameterbeing monitored. Other components provide for producing direct orindirect actions, acting on another device, or adjusting another deviceor article of manufacture based on the biological parameter measured.

The search for a better way to measure biological parameters hasresulted in long and careful research, which included the discovery of aBrain Temperature Tunnel (BTT) and other physiologic tunnels in humansand animals. The present invention was the first to recognize thephysiologic tunnel in the body. The present invention was yet the firstto recognize the end of the tunnel on the skin surface in which anoptimal signal is acquired and measurements can be done without thepresence of interfering constituents and background noise that exceedsthe signal being measured. The present invention was also the first torecognize and precisely map the special geometry and location of thetunnel including the main entry point. The present invention was yetfirst to recognize the precise positioning of sensing systems at themain entry point for optimal signal acquisition. Careful studies havebeen undertaken including software development for characterizinginfrared radiation to precisely determine the different aspects of thetunnel. This research has determined that the measurement of brain(core) temperature and other body parameters can be accomplished in anon-invasive and continuous manner in humans and animals with sensorspositioned in a confined area of the skin at the end of a physiologictunnel.

The key function and critical factor for life preservation and humanperformance is brain temperature. Brain tissue is the tissue in the bodymost susceptible to thermal damage, by both high and low temperature.Brain temperature is the most clinically relevant parameter to determinethe thermal status of the body and the human brain is responsible for 18to 20% of the heat produced in the body, which is an extraordinary factconsidering that the brain represents only 2% of the body weight. Thegreat amount of thermal energy generated in the brain is kept in aconfined space and the scalp, skull, fat and CSF (cerebral spinal fluid)form an insulating layer. The recognition of the BTT by the presentinvention bypasses the insulating barriers and provides a directconnection to inside the brain physiology and physics.

Anatomically and physiologically speaking, a Brain Temperature Tunnelconsists of a continuous, direct, and undisturbed connection between theheat source within the brain and an external point at the end of thetunnel. The physical and physiological events at one end of the tunnelinside the brain are reproduced at the opposite end on the skin. A BTTenables the integral and direct heat transfer through the tunnel withoutinterference by heat absorbing elements, i.e., elements that can absorbfar-infrared radiation transmitted as heat by blood within the brain.There are six characteristics needed to define a BTT. Thesecharacteristics are:

-   -   1) area without heat absorbing elements, i.e., the area must not        contain adipose tissue (fat tissue). This is a key and needed        characteristic for defining a temperature tunnel,    -   2) area must have a terminal branch of a vessel in order to        deliver the integral amount of heat,    -   3) terminal branch has to be a direct branch of a blood vessel        from the brain,    -   4) terminal branch has to be superficially located to avoid heat        absorption by deep structures such as muscles,    -   5) area must have a thin and negligible interface between a        sensor and the source of thermal energy to achieve high heat        flow, and    -   6) area must not have thermoregulatory arteriovenous shunts.

All six characteristics are present on the skin on the medial canthalarea adjacent to the medial corner of the eye above the medial canthaltendon and in the medial third of the upper eyelid. In more detail theend of BTT area on the skin measures about 11 mm in diameter measuredfrom the medial corner of the eye at the medial canthal tendon andextends superiorly for about 6 mm and then extends into the upper eyelidin a horn like projection for another 22 mm.

The BTT area is the only area in the body without adipose tissue, whichis in addition supplied by a terminal branch, which has a superficialblood vessel coming from the brain vasculature, and which has a thininterface and no thermoregulatory shunts. The BTT area is supplied by aterminal branch of the superior ophthalmic vein which is a directconnection to the cavernous sinus, said cavernous sinus being anendothelium-lined system of venous channels inside the brain whichcollects and stores thermal energy. The blood vessel supplying the BTTarea is void of thermoregulatory arteriovenous shunts and it ends on theskin adjacent to the medial corner of the eye and in the superior aspectof the medial canthal area right at the beginning of the upper eyelid.The blood vessels deliver undisturbed heat to the skin on the medialcanthal area and upper eyelid as can be seen in the color as well asblack and white photos of infrared images shown in FIGS. 1 and 2. Theundisturbed thermal radiation from the brain is delivered to the surfaceof the skin at the end of the tunnel. The heat is delivered to an areaof skin without fat located at the end of the tunnel. The blood vesseldelivering heat is located just below the skin and thus there is noabsorption of infrared radiation by deep structures.

If the blood vessel is located deep, other tissues and chemicalsubstances would absorb the heat, and that can invalidate the clinicalusefulness of the measurement. There is direct heat transfer and theskin in the BTT area is the thinnest skin in the body and is void ofthermoregulatory arteriovenous shunts. A very important aspect foroptimal measurement of temperature is no interference by fat tissue anddirect heat transfer.

The absence of fat tissue in this particular and unique area in the bodyat the end of the tunnel allows the undisturbed acquisition of thesignal. The combination of those six elements allows the undisturbed andintegral emission of infrared radiation from the brain in the form ofdirect heat transfer at the BTT area location, which can be seen in theinfrared image photographs (FIGS. 1 to 8). The BTT and physiologictunnels are also referred in this description as the “Target Area”.

From a physical standpoint, the BTT is the equivalent of a Brain ThermalEnergy tunnel with high total radiant power and high heat flow. Thetemperature of the brain is determined by the balance between thermalenergy produced due to metabolic rate plus the thermal energy deliveredby the arterial supply to the brain minus the heat that is removed bycerebral blood flow. Convection of heat between tissue and capillariesis high and the temperature of the cerebral venous blood is inequilibrium with cerebral tissue. Accordingly, parenchymal temperatureand thermal energy of the brain can be evaluated by measuring thetemperature and thermal energy of the cerebral venous blood. Thesuperior ophthalmic vein has a direct and undisturbed connection to thecavernous sinus and carries cerebral venous blood with a thermal energycapacity of 3.6 J·ml⁻¹·(° C.)⁻¹ at hematocrit of 45%. Cerebralthermodynamic response, thermal energy, and brain temperature can beevaluated by placing a sensor to capture thermal energy conveyed by thecerebral venous blood at the end of the BTT.

The research concerning BTT and physiologic tunnels involved variousactivities and studies including: 1) In-vitro histologic analysis ofmucosal and superficial body areas; 2) In-vivo studies with temperatureevaluation of external areas in humans and animals; 3) In-vivofunctional angiographic evaluation of heat source; 4) Morphologicstudies of the histomorphometric features of the BTT area; 5) In-vivoevaluation of temperature in the BTT area using: thermocouples,thermistors, and far-infrared; 6) Comparison of the BTT areameasurements with the internal eye anatomy and current standard mostused (oral) for temperature measurement; 7) Cold and heat challenge todetermine temperature stability of BTT; and 8) Infrared imaging andisotherm determination. Software for evaluating geometry of tunnel wasalso developed and used. Simultaneous measurement of a referencetemperature and temperature in the BTT area were done using pre-equallycalibrated thermistors. A specific circuit with multiple channels wasdesigned for the experiments and data collection.

The measurement of temperature in the BTT area showed almost identicaltemperature signal between the BTT area and the internal conjunctivalanatomy of the eye, which is a continuation of the central nervoussystem. Measurement of the temperature in the internal conjunctivalanatomy of eye as used in the experiment was described by Abreu in U.S.Pat. Nos. 6,120,460 and 6,312,393. The averaged temperature levels forBTT and internal eye were within 0.1° C. (0.18° F.) with an averagenormothermia value equivalent of 37.1° C. (98.8° F.) for the BTT and 37°C. (98.6° F.) for the internal eye. Comparison with the standard mostused, oral temperature, was also performed. The temperature voltagesignal of the BTT area showed an average higher temperature level in theBTT area of an equivalent of 0.3° C. (0.5° F.) when compared to oral.

Subjects underwent cold challenge and heat challenge through exercisingand heat room. The lowering and rising of temperature in the BTT areawas proportional to the lowering and rising in the oral cavity. However,the rate of temperature change was faster in the BTT area than for oralby about 1.2 minutes, and temperature at the BTT site was 0.5° C. (0.9°F.) higher on few occasions. Subjects of different race, gender, and agewere evaluated to determine the precise location of the BTT area acrossa different population and identify any anatomic variation. The locationof the BTT was present at the same location in all subjects with nosignificant anatomic variation, which can be seen in a sample ofinfrared imaging of different subjects.

The tunnel is located in a crowded anatomic area and thus thepositioning of the sensor requires special geometry for optimalalignment with the end of the tunnel. The clinical usefulness of thetunnel can only be achieved with the special positioning of the sensorin relation to anatomic landmarks and the support structure. The tunnelis located in a unique position with distinctive anatomic landmarks thathelp define the external geometry and location of the end of the tunnel.The main entry point of the tunnel, which is the preferred location forpositioning the sensor, requires the sensor to be preferably placed inthe outer edge of a support structure. The preferred embodiment for themeasurement of biological parameters by accessing a physiologic tunnelincludes sensors positioned in a particular geometric position on thesupport structure.

The support structure includes patches containing sensors. For thepurpose of the description any structure containing an adhesive as meansto secure said structure to the skin at the end of the tunnel isreferred to as a patch including strips with adhesive surfaces such as a“BAND-AID” adhesive bandage. It is understood that a variety ofattachment means can be used including adhesives, designs incorporatingspring tension pressure attachment, and designs based on otherattachment methods such as elastic, rubber, jelly-pads and the like.

The patches are adapted to position sensors at the end of the tunnel foroptimal acquisition of the signal. The patch is preferably secured tothe area by having an adhesive backing which lays against the skin,although a combination of adhesive and other means for creating a stableapposition of the sensor to the tunnel can be used such as fastening orpressure.

Support structures also include clips or structures that are positionedat the end of the tunnel with or without adhesive and which are securedto the area by pressure means. Any structure that uses pressure means tosecure said structure to the skin at the end of the tunnel is referredas a clip.

Head-mounted structures are structures mounted on the head or neck forpositioning sensors on the end of the tunnel and include head bands withaccessories that are adjacent to the tunnel, visors, helmets, headphone,structures wrapping around the ear and the like. For the purpose of thisdescription TempAlert is referred herein as a system that measurestemperature in the BTT area and has means to report the measured valueand that can incorporate alarm devices that are activated when certainlevels are reached. Support structures yet include any article that hassensing devices in which said sensing devices are positioned at the endof the tunnel.

Support structures further include medial canthal pieces of eyeglasses.A medial canthal piece is also referred to herein as a medial canthalpad and includes a pad or a piece which positions sensing devices on theskin at the medial canthal area on top of a tunnel, with said medialcanthal piece being permanently attached to or mounted to an eyeglass.Any sensing devices incorporated in an eyeglass (fixed or removable) foraccessing a tunnel are referred to herein as EyEXT including devices forsensing physical and chemical parameters. Any article of manufacturethat has visual function, or ocular protection, or face protection witha part in contact with the tunnel is referred herein as eyeglasses andincludes conventional eyeglasses, prescription eyeglasses, readingglasses, sunglasses, goggles of any type, masks (including gas masks,surgical masks, cloth masks, diving masks, eyemask for sleeping and thelike) safety glasses, and the like.

For brain temperature evaluation the tunnel area consists of the medialcanthal area and the superior aspect of the medial corner of the eye.For brain function evaluation the tunnel area consists of primarily theupper eyelid area. For metabolic function evaluation the tunnel areaconsists of an area adjacent to the medial corner of the eye and boththe upper and lower eyelids.

The measurement of metabolic function, brain function, immunogenicfunction, physical parameters, physico-chemical parameters and the likeincludes a variety of support structures with sensors accessing thephysiologic tunnels. The sensors are placed in apposition to the skinimmediately adjacent to the medial corner of the eye preferably in thesuperior aspect of the medial canthal area. The sensor can also bepositioned in the medial third of the upper eyelid. The sensor is mostpreferably located at the main entry point of the tunnel which islocated on the skin 2.5 mm medial to the corner of the eye and about 3mm above the medial corner of the eye. The diameter of the main entrypoint is about 6 to 7 mm. The positioning of the sensor at the mainentry point of the tunnel provides the optimum site for measuringphysical and chemical parameters of the body.

Besides a sensor that makes contact with the skin at the Target Area, itis understood that sensors which do not make contact with the skin canbe equally used. For instance an infrared-based temperature measuringsystem can be used. The measurement is based on the Stefan-Boltzman lawof physics in which the total radiation is proportional to the fourthpower of the absolute temperature, and the Wien Displacement law inwhich the product of the peak wavelength and the temperature areconstant. The field of view of the non-contact infrared apparatus of theinvention is adapted to match the size and geometry of the BTT area onthe skin.

A variety of lenses known in the art can be used for achieving the fieldof view needed for the application. For example, but not by way oflimitation, a thermopile can be adapted and positioned in a manner tohave a field of view aimed at the main entry point of the BTT area onthe skin. The signal is then amplified, converted into a voltage outputand digitized by a MCU (microcontroller).

This infrared-based system can be integrated into a support structurethat is in contact with the body such as any of the support structuresof the present invention. In addition, it is understood that theinfrared-based system of the present invention can be integrated as aportable or hand-held unit completely disconnected from the body. Theapparatus of the present invention can be held by an operator that aimssaid apparatus at the BTT area to perform the measurement. The apparatusfurther includes an extension shaped to be comfortably positioned at theBTT site for measuring biological parameters without discomfort to thesubject. The extension in contact with the skin at the BTT is shaped inaccordance with the anatomic landmarks and the geometry and size of theBTT site. The infrared radiation sensor is positioned in the extensionin contact with the skin for receiving radiation emitted from the BTTsite.

The present invention provides a method for measuring biologicalparameters including the steps of positioning a sensing device means onthe skin area at the end of a tunnel, producing a signal correspondingto the biological parameter measured and reporting the value of theparameter measured.

It is also includes a method to measure biological parameters bynon-contact infrared thermometry comprising the steps of positioning aninfrared detector at the BTT site with a field of view that encompassesthe BTT site and producing a signal corresponding to the measuredinfrared radiation. The biological parameters include temperature, bloodchemistry, metabolic function and the like.

Temperature and ability to do chemical analysis of blood components isproportional to blood perfusion. The present invention recognizes thatthe tunnel area, herein also referred as a Target Area, has the highestsuperficial blood perfusion in the head and has a direct communicationwith the brain, and that the blood vessels are direct branches of thecerebral vasculature and void of thermoregulatory arteriovenous shunts.It was also recognized that the Target Area has the highest temperaturein the surface of the body as can be seen in the photographs ofexperiments measuring infrared emission from the body and the eye.

The Target Area discovered not only has the thinnest and mosthomogeneous skin in the whole body but is the only skin area without afat layer. Since fat absorbs significant amounts of radiation, there isa significant reduction of signal. Furthermore other skin areas onlyprovide imprecise and inaccurate signals because of the large variationof adipose tissue from person to person and also great variability offat tissue according to age. This interference by a fat layer does notoccur in the Target Area. Furthermore, the combined characteristics ofthe Target Area, contrary to the skin in the rest of the body, enablethe acquisition of accurate signals and a good signal to noise ratiowhich far exceeds background noise. In addition, body temperature suchas is found in the surface of the skin in other parts of the body isvariable according to the environment.

Another important discovery of the present invention was thedemonstration that the Target Area is not affected by changes in theenvironment (experiments included cold and heat challenge). The TargetArea provides an optimum location for temperature measurement which hasa stable temperature and which is resistant to ambient conditions. TheTarget Area discovered has a direct connection to the brain, is notaffected by the environment and provides a natural, complete thermalseal and stable core temperature. The apparatus and methods of thepresent invention achieve precision and clinical usefulness needed withthe non-invasive placement of a temperature sensor on the skin in directcontact with the heat source from the brain without the interference ofheat absorbing elements.

The Target Area is extremely vascularized and is the only skin area inwhich a direct branch of the cerebral vasculature is superficiallylocated and covered by a thin skin without a fat layer. The main trunkof the terminal branch of the ophthalmic vein is located right at theBTT area and just above the medial canthal tendon supplied by the medialpalpebral artery and medial orbital vein. The BTT area on the skinsupplied by a terminal and superficial blood vessel ending in aparticular area without fat and void of thermoregulatory arteriovenousshunts provides a superficial source of undisturbed biological signalsincluding brain temperature, metabolic function, physical signals, andbody chemistry such as glucose level, and the like.

Infrared spectroscopy is a technique based on the absorption of infraredradiation by substances with the identification of said substancesaccording to its unique molecular oscillatory pattern depicted asspecific resonance absorption peaks in the infrared region of theelectromagnetic spectrum. Each chemical substance absorbs infraredradiation in a unique manner and has its own unique absorption spectradepending on its atomic and molecular arrangement and vibrational androtational oscillatory pattern. This unique absorption spectra allowseach chemical substance to basically have its own infrared spectrum,also referred to as fingerprint or signature which can be used toidentify each of such substances. Radiation containing various infraredwavelengths is emitted at the substance to be measured and the amount ofabsorption of radiation is dependent upon the concentration of saidchemical substance being measured according to Beer-Lambert's Law.

Interfering constituents and variables such as fat, bone, muscle,ligaments and cartilage introduce significant source of errors which areparticularly critical since the background noise greatly exceeds thesignal of the substance of interest. Since those interferingconstituents are not present on the skin at the BTT area, the sensingsystems positioned at said BTT area can acquire optimal signal withminimal noise including spectroscopic-based measurements.

Spectroscopic devices integrated into support structures disclosed inthe present invention can precisely non-invasively measure bloodcomponents since the main sources of variation and error, such as fattissue, are not present in the Target Area. In addition, other keyconstituents which interfere with electromagnetic energy emission suchas muscle, cartilage and bones, are not present in the Target Areaeither. The blood vessels delivering the infrared radiation aresuperficially located and the infrared radiation is delivered at the endof the tunnel without interacting with other structures. The onlystructure to be traversed by the infrared radiation is a very thin skin,which does not absorb the infrared wavelength. The present inventionincludes infrared spectroscopy means to provide a clinically usefulmeasurement with the precise and accurate determination of theconcentration of the blood components at the end of the tunnel.

In addition to spectroscopy in which electromagnetic energy is deliveredto the Target Area, the present invention also discloses apparatus andmethods for measuring substances of interest through far infraredthermal emission from the Target Area. Yet, besides near-infraredspectroscopy and thermal emission, other devices are disclosed formeasurement of substances of interest at the Target Area includingelectroosmosis as a flux enhancement by iontophoresis or reverseiontophoresis with increased passage of fluid through the skin throughapplication of electrical energy. Yet, transcutaneous optical devicescan also be integrated into support structures including medial canthalpieces, modified nose pads, and the frame of eyeglasses, with saiddevices positioned to access the tunnel.

It is understood that application of current, ultrasonic waves as wellas chemical enhancers of flow, electroporation and other devices can beused to increase permeation at the tunnel site such as for exampleincreased flow of glucose with the use of alkali salts. In additioncreating micro holes in the target area with a laser, or other meansthat penetrate the skin can be done with the subsequent placement ofsensing devices on the BTT site, with said devices capable of measuringchemical compounds. Furthermore, reservoirs mounted on or disposedwithin support structures, such as the frame and pads of eyeglasses, candeliver substances transdermally at the BTT site by various devicesincluding iontophoresis, sonophoresis, electrocompression,electroporation, chemical or physical permeation enhancers, hydrostaticpressure and the like.

In addition to measure the actual amount of oxygen in blood, the presentinvention also discloses devices to measure oxygen saturation and theamount of oxygenated hemoglobin. In this embodiment the medial canthalpiece of a support structure or the modified nose pads of eyeglassescontain LEDs emitting at two wave lengths around 940 and 660 nanometers.As the blood oxygenation changes, the ratio of the light transmitted bythe two frequencies changes indicating the oxygen saturation. Since theblood level is measured at the end of a physiologic brain tunnel, theamount of oxygenated hemoglobin in the arterial blood of the brain ismeasured, which is the most valuable and key parameter for athleticpurposes and health monitoring.

The present invention also provides a method for measuring biologicalparameters with said method including the steps of directingelectromagnetic radiation at the BTT area on the skin, producing asignal corresponding to the resulting radiation and converting thesignal into a value of the biological parameter measured.

Besides using passive radio transmission or communication by cable;active radio transmission with active transmitters containing amicrominiature battery mounted in the support structure can also beused. Passive transmitters act from energy supplied to it from anexternal source. The transensor transmits signals to remote locationsusing different frequencies indicative of the levels of biologicalparameters. Ultrasonic micro-circuits can also be mounted in the supportstructure and modulated by sensors which are capable of detectingchemical and physical changes at the Target Area. The signal may betransmitted using modulated sound signals particularly under waterbecause sound is less attenuated by water than are radio waves.

One preferred embodiment comprises a support structure including a patchadapted to be worn on or attached with adhesives to the tunnel andincludes structural support, a sensor for measuring biologicalparameters, power source, microcontroller and transmitter. The parts canbe incorporated into one system or work as individual units. The sensoris located preferably within 7 mm from the outer edge of the patch. Theapparatus of the invention can include a temperature sensor located inthe outer edge of the patch for sensing temperature. The transmitter,power source and other components can be of any size and can be placedin any part of the patch or can be connected to the patch as long as thesensing part is placed on the edge of the patch in accordance with theprinciples of the invention. The sensor in the patch is positioned onthe skin adjacent to the medial canthal area (medial corner of the eye)and located about 2 mm from the medial canthal tendon. The sensor canpreferably include electrically-based sensors, but non-electricalsystems can be used such as chemicals that respond to changes intemperature including mylar.

Besides patches, another preferred embodiment for measuring biologicalparameters at the physiologic tunnel includes a medial canthal pad. Themedial canthal piece is a specialized structure containing sensors foraccessing the tunnel and adapted to be worn on or attached to eyeglassesin apposition to the tunnel and includes structural support, a sensorfor measuring biological parameters, power source, microcontroller andtransmitter. The parts can be incorporated into one system or work asindividual units. The sensors are positioned on the BTT area. Thetransmitter, power source, and other components can be placed in themedial canthal pad or in any part of the eyeglasses. A medial canthalpiece or extension of nose pads of eyeglasses allow accessing thephysiologic tunnel with sensing devices laying in apposition to the BTTarea.

The apparatus of the invention include a temperature sensor located inthe medial canthal pad. For temperature measurement the sensing systemis located on a skin area that includes the medial canthal corner of theeye and upper eyelid. The sensor in the medial canthal pad is preferablypositioned on the skin adjacent to the medial canthal area (medialcorner of the eye). Although one of the preferred embodiments formeasurement of brain temperature consists of medial canthal pads, it isunderstood that also included in the scope of the invention are nosepads of a geometry and size that reach the tunnel and that are equippedwith temperature sensors preferably in the outer edge of said nose padsfor measuring brain temperature and other functions. An oversized andmodified nose pad containing sensors using a special geometry foradequate positioning at the BTT area is also included in the invention.

With the disclosure of the present invention and by using anatomiclandmarks in accordance with the invention the sensor can be preciselypositioned on the skin at the end of the tunnel. However, since there isno external visible indication on the skin relating to the size orgeometry of the tunnel, accessory means can be used to visualize, map ormeasure the end of the tunnel on the skin. These accessory means may beparticularly useful for fitting medial canthal pads or modified nosepads of eyeglasses.

Accordingly, an infrared detector using thermocouple or thermopiles canbe used as an accessory for identifying the point of maximum thermalemission and to map the area. An infrared imaging system or thermographysystem may be preferably used. In this instance, an optical storeselling the eyeglasses can have a thermal imaging system. The optician,technician and the like take an infrared image picture or film the area,and in real time localize the tunnel of the particular user. The medialcanthal pads or modified nose pads can then be adjusted to fit theparticular user based on the thermal infrared imaging. The eyeglassesare fitted based on the thermal image created. This will allowcustomized fitting according to the individual needs of the user. Anythermography-based system can be used including some with great visualimpact and resolution as a tri-dimensional color thermal wave imaging.

It is also a feature of the invention to provide a method to be used forexample in optical stores for locating the tunnel including the steps ofmeasuring thermal infrared emission, producing an image based on theinfrared emission, and detecting the area with the highest amount ofinfrared emission. Another step that can be included is adjustingsensors in support structures to match the area of highest infraredemission.

One of said support structures includes the medial canthal pieces ornose pads of eyeglasses. The thermal imaging method can be used forfitting a patch, but said patch can be positioned at the tunnel byhaving an external indicator for lining up said indicator with apermanent anatomic landmark such as the medial corner of the eye.Although medial canthal pieces of eyeglasses can have an externalindicator for precise positioning, since opticians are used to fiteyeglasses according to the anatomy of the user, the thermal imagingmethod can be a better fit for eyeglasses than an external indicator onthe medial canthal pieces or modified nose pads of eyeglasses.

The source of the signal is key for the clinical usefulness of themeasurement. The brain is the key and universal indicator of the healthstatus of the body. The signal coming from the brain or brain areaprovides the most clinically useful data. In accordance with anotherembodiment, the measurement of biological parameters will be described.The amount of sodium and other elements in sweat is a key factor forsafety and performance of athletes and military, as well as healthmonitoring.

For instance hyponatremia (decreased amount of sodium) can lead toreduced performance and even death. Hyponatremia can occur due to excesswater intake, commonly occurring with intense physical activity andmilitary training. Sweat can be considered as an ultrafiltrate of blood.The blood vessels supplying the skin on the head are branches of thecentral nervous system vasculature. The amount of chemical substancespresent in the sweat coming from those blood vessels is indicative ofthe amount of chemical substances present in the cerebral vasculature.For instance, sodium concentration of sweat from blood vessels in thehead changes in relation to the rates of sweating. The apparatus andmethods of the present invention can prevent death or harm due to waterintoxication, by providing alert signals when the levels of sodium insweat reach a certain threshold for that particular wearer. The presenceof various chemical elements, gases, electrolytes and pH of sweat andthe surface of the skin can be determined by the use of suitableelectrodes and suitable sensors integrated in the eyeglasses and othersupport structures mounted on the head or fitted on the head or face.These electrodes, preferably microelectrodes, can be sensitized byseveral reacting chemicals which are in the sweat or the surface of theskin. The different chemicals and substances can diffuse throughsuitable permeable membranes sensitizing suitable sensors.

For example but not by way of limitation, electrochemical sensors can beused to measure various analytes such as glucose using a glucose oxidasesensor and the pilocarpine iontophoresis method can be used to measureelectrolytes in sweat alone or in conjunction with microfluidics system.Besides the support structures of the present invention, it is alsounderstood that other articles such as watches, clothing, footwear andthe like can be adapted to measure concentration of substances such aselectrolytes present in sweat, however there is reduced clinicalrelevance for evaluating metabolic state of an individual outside thecentral nervous system.

Body abnormalities may cause a change in the pH, osmolarity, andtemperature of the sweat derived from brain and neck blood vessels aswell as change in the concentration of substances such as acid-lactic,glucose, lipids, hormones, gases, markers, infectious agents, antigens,antibody, enzymes, electrolytes such as sodium, potassium and chloride,and the like. Eyeglasses and any head gear can be adapted to measure theconcentration of substances in sweat. Microminiature glass electrodesmounted in the end portion of the temple of eyeglasses sitting behindthe ear or alternatively mounted on the lens rim against the foreheadcan be used to detect divalent cations such as calcium, as well assodium and potassium ion and pH. Chloride-ion detectors can be used todetect the salt concentration in the sweat and the surface of the skin.

Many agents including biological warfare agents and HIV virus arepresent in sweat and could be detected with the eyeglasses or supportstructure on the head or face using sensors coated with antibodiesagainst the agent which can create a photochemical reaction withappearance of colorimetric reaction and/or potential shift withsubsequent change in voltage or temperature that can be detected andtransmitted to a monitoring station or reported locally by audio orvisual means. Electrocatalytic antibodies also can generate anelectrical signal when there is an antigen-antibody interaction. It isalso understood that other articles such as watches, clothing, footwear,and the like or any article capturing sweat can be adapted to identifyantigens, antibody, infectious agents, markers (cancer, heart, genetic,metabolic, drugs, and the like) in accordance with the presentinvention. However, identification of those elements away from thecentral nervous system is of reduced clinical relevance.

The different amounts of fluid encountered in sweat can be easilyquantified and the concentration of substances calibrated according tothe amount of fluid in sweat. The relationship between the concentrationof chemical substances and molecules in the blood and the amount of saidchemical substances in the sweat can be described mathematically andprogrammed in a computer.

The present invention also includes eyeglasses or support structures inwhich a radio frequency transensor capable of measuring the negativeresistance of nerve fibers is mounted in the eyeglasses or supportstructure. By measuring the electrical resistance, the effects ofmicroorganisms, drugs, and poisons can be detected. The system alsocomprises eyeglasses in which a microminiature radiation-sensitivetransensor is mounted in said eyeglasses or support structure.

The brain has a rich vasculature and receives about 15% of the restingcardiac output and due to the absence of fat the tunnel offers an areafor optimal signal acquisition for evaluating hemodynamics. Accordingly,change in the viscosity of blood can be evaluated from a change indamping on a vibrating quartz micro-crystal mounted in the eyeglasses orsupport structure and the invention can be adapted to measure bloodpressure and to provide instantaneous and continuous monitoring of bloodpressure through an intact wall of a blood vessel from the brain and toevaluate hemodynamics and hydrodynamics. Also, by providing a contactmicrophone, arterial pressure can be measured using sonic devices.

Pressure can be applied to a blood vessel through a micro cuff mountedin the medial canthal pads, or alternatively by the temples ofeyeglasses. Pressure can also be applied by a rigid structure, and thepreferred end point is reached when sound related to blood turbulence isgenerated. The characteristic sound of systole (contraction of theheart) and diastole (relaxation of the heart) can be captured by themicrophone. A microphone integrated into the medial canthal pad can beadapted to identify the heart sounds. Pressure transducers such as acapacitive pressure transducer with integral electronics for signalprocessing and a microphone can be incorporated in the same siliconstructure and can be mounted in the medial canthal pad. Motion sensorsand/or pressure sensors can be mounted in the medial canthal pad tomeasure pulse.

Reversible mechanical expansion methods, photometric, or electrochemicalmethods and electrodes can be mounted in the eyeglasses or supportstructures of the present invention and used to detect acidity, gases,analyte concentration, and the like. Oxygen gas can also be evaluatedaccording to its magnetic properties or be analyzed bymicro-polarographic sensors mounted in the eyeglasses or other supportstructure. A microminiature microphone mounted in the eyeglasses orother support structure can also be adapted to detect sounds from theheart, respiration, flow, vocal and the environment, which can be sensedand transmitted to a remote receiver or reported by local audio andvisual means. The sensors are adapted and positioned to monitor thebiological parameters at the end of the tunnel.

The eyeglasses or other support structures can also have elements whichproduce and radiate recognizable signals and this procedure could beused to locate and track individuals, particularly in militaryoperations. A permanent magnet can also be mounted in the eyeglasses andused for tracking as described above. A fixed frequency transmitter canbe mounted in the eyeglasses and used as a tracking device whichutilizes a satellite tracking system by noting the frequency receivedfrom the fixed frequency transmitter to a passing satellite, or viaGlobal Positioning Systems. Motion and deceleration can be detected bymounting an accelerometer in the eyeglasses. The use of eyeglasses astracking devices can be useful for locating a kidnapped individual orfor rescue operations in the military, since eyeglasses are normallyunsuspecting articles.

The use of integrated circuits and advances occurring in transducer,power source, and signal processing technology allow for extrememiniaturization of the components which permits several sensors to bemounted in one unit.

The present invention provides continuous automated brain temperaturemonitoring without the need for a nurse. The present invention canidentify a spike in temperature. Thus, proper diagnosis is made andtherapy started in a timely fashion. Time is critical for identifyingthe temperature spike and organism causing the infection. Delay inidentifying spike and starting therapy for the infection can lead todemise of the patient. The invention timely and automatically identifiesthe temperature spike and prevents the occurrence of complications.

The present invention also alerts the user about overheating orhypothermia to allow:

-   -   1. Proper hydration;    -   2. Increased performance;    -   3. Increased safety; and    -   4. Feed back control in treadmills and other exercise machines        for keeping proper hydration and performance.

Annually many athletes, construction workers, college students and thegeneral public unnecessarily die due to heatstrokes. Once the brainreaches a certain temperature level such as 40° C., an almostirreversible process ensues. Because there are no specific symptoms andafter a certain point there is rapid increase in brain temperature,heatstroke has one of the highest fatality rates. The more severe andmore prolonged the episode, the worse the predicted outcome, especiallywhen cooling is delayed. Without measuring core temperature and havingan alert system when the temperature falls outside safe levels it isimpossible to prevent hyperthermia and heatstroke. The present inventionprovides a device for continuous monitoring of temperature with alertsystems that can prevent dangerous levels to be reached and coolingmeasures applied if needed. The apparatus can be adapted to be used inan unobtrusive manner by athletes, military, workers and the generalpopulation.

All chemical reactions in the body are dependent on temperature. Hightemperature can lead to enzymatic changes and protein denaturation andlow temperature can slow down vital chemical reactions. Hydration isdependent on brain temperature and loss of fluid leads to a rise inbrain temperature. Minimal fluctuations in the body's temperature canadversely affect performance and increase risk of illness and of lifethreatening events. Therefore, it is essential that athletes, sportsparticipants, military personnel, police officers, firefighters, forestrangers, factory workers, farmers, construction workers and otherprofessionals have precise mechanisms to know exactly what is theirbrain temperature.

When the core temperature rises, the blood that would otherwise beavailable for the muscles is used for cooling via respiration andperspiration. The body will do this automatically as temperature movesout of the preferred narrow range. It is this blood shifting thatultimately impairs physical performance and thermal induced damage tobrain tissue interferes with normal cognitive function. Intense exercisecan increase heat production in muscles 20 fold. In order to preventhyperthermia and death by heat stroke athletes drink water. Because theingestion of water is done in a random fashion, many times there iswater intoxication which can lead to death as occurs to many healthypeople including marathon runners and military personnel. Both, excessof water (overhydration) or lack of water (dehydration) can lead tofatal events besides reducing performance. Therefore, it is essentialthat individuals have precise means to know exactly when and how much todrink. By monitoring brain temperature with the present invention properhydration can be achieved and athletes and military will know preciselywhen and how much water to ingest.

Timely ingestion of fluids according to the core temperature allowsoptimization of cardiovascular function and avoidance of heat strain.Because there is a delay from the time of ingestion of fluid toabsorption of said fluid by the body, the method of invention includessignaling the need for ingestion at a lower core temperature such as38.5° C. to account for that delay, and thus avoid the onset ofexhaustion. The temperature threshold can be adjusted according to eachindividual, the physical activity, and the ambient temperature.

In addition, software can be produced based on data acquired at the BTTsite for optimizing fitness, athletic performance, and safety. The uppertemperature limit of a particular athlete for maintaining optimalperformance can be identified, and the data used to create software toguide said athlete during a competition. For instance, the athlete canbe informed on the need to drink cold fluid to prevent reaching acertain temperature level which was identified as reduced performancefor said athlete. Brain temperature level for optimal performanceidentified can be used to guide the effort of an athlete duringcompetition and training. Hyperthermia also affects mental performanceand software based on data from the BTT can be produced to optimizemental and physical performance of firefighters in an individual manner.People can have different thresholds for deleterious effects ofhyperthermia and thus setting one level for all users may lead tounderutilization of one's capabilities and putting others at risk ofreduced performance. Likewise, exercise endurance and mental performanceis markedly reduced by hypothermia and the same settings can be appliedfor low temperature situations. Determinations of brain temperature,oxygen and lactic acid levels can also be used for endurance training ofathletes, fitness training, and to monitor the effects of training. Thesystem, method, and apparatus of the invention provides a mechanism forenhancing safety and optimizing fitness for athletes and recreationalsports participants.

It is a feature of the invention to provide a method for the precise andtimely intake of fluids including the steps of measuring braintemperature, reporting the signal measured, and ingesting an amount offluid based on the signal measured. Other steps can be included such asreporting devices using voice reproduction or visual devices to instructon what beverage to drink and how much to drink to reduce coretemperature. It is understood that the method of the present inventioncan combine measurement of temperature associated with measurement ofsodium in sweat or blood, in accordance with the principles of theinvention.

Children do not tolerate heat as well as adults because their bodiesgenerate more heat relative to their size than adults do. Children arealso not as quick to adjust to changes in temperatures. In addition,children have more skin surface relative to their body size which meansthey lose more water through evaporation from the skin. It is understoodthat different sizes, shapes, and designs of medial canthal padsincluding children size can be used in the present invention. Childreneyeglasses equipped with sensors can have a booster radio transmitterthat will transmit the signal to a remote receiver and alert parentsabout dangerous temperature levels. The eyeglasses can be incorporatedwith a detecting system to send a signal if the eyeglasses were removedor if the temperature sensor is not capturing signals in a propermanner. By way of illustration, but not of limitation, pressure sensingdevices can be incorporated in the end of the temples to detect if thesunglasses are being worn, and an abrupt drop in the pressure signalindicates glasses were removed or misplacement of the sensor can alsogenerate an identifiable signal. An adhesive, a double-sided adhesivetape, or other devices for increasing grip can be used in the medialcanthal pads to ensure more stable position. It is understood that theeyeglasses can come equipped with sensors to detect ambient temperatureand humidity, which allows for precisely alerting the wearer about anyaspect affecting heat conditions.

In the current industrial, nuclear and military settings, personnel maybe required to wear protective clothing. Although the protectiveclothing prevent harm by hazardous agents, the garments increase therate of heat storage. It is understood that the present invention can becoupled with garments with adjustable permeability to automatically keepthe core temperature within safe limits.

In addition, the present invention alerts an individual about risk ofthermal damage (risk of wrinkles and cancer) at the beach or duringoutdoor activities. When one is at the beach, watching a game in astadium, camping or being exposed to the sun, the radiant energy of thesun is absorbed and transformed into thermal energy. The combination ofthe different ways of heat transfer to the body lead to an increase inbody temperature, which is reflected by the brain temperature.Convection and conduction can also lead to an increase in bodytemperature through heat transfer in the absence of sun light. Theabsorption of heat from the environment leads to a rise in the averagekinetic energy of the molecules with subsequent increase in coretemperature.

The levels of core temperature is related to the risk of thermal damageto the skin. After certain levels of heat there is an increased risk ofdenaturing protein and breaking of collagen in the skin. This can becompared with changes that occur when frying an egg. After a certainamount of thermal radiation is delivered the egg white changes fromfluidic and transparent to a hard and white structure. After the eggwhite reaches a certain level of temperature the structural changebecomes permanent. After a certain level of increase in core temperatureduring sun exposure, such as a level of 37.7° Celsius to 37.9° Celsiusat rest (e.g.; sun bathing), thermal damage may ensue and due to thedisruption of proteins and collagen there is an increased risk forwrinkle formation. The increased brain temperature correlates to theamount of thermal radiation absorbed by the body, and the duration ofexposure of the temperature level times the level of temperature is anindicator of the risk of thermal damage, wrinkle formation, and skincancer.

The present invention provides an alarm system that can be set up toalert in real time when it is time to avoid sun exposure in order toprevent further absorption of thermal radiation and reduce the risk ofdermatologic changes, as can occur during outdoor activities or at thebeach. In addition, thermal damage to the skin prevents the skin fromadequately cooling itself and can result in increasing the risk ofdehydration which further increases the temperature. The presentinvention helps preserve the beauty and health of people exposed to sunlight and during outdoor activities while allowing full enjoyment of thesun and the benefits of sun light.

By the present invention, a method for timing sun exposure includes thesteps of measuring body temperature, reporting the value measured andavoiding sun exposure for a certain period of time based on the levelmeasured.

Hypothermia is the number one killer in outdoor activities in the U.S.and Europe. Hypothermia also decreases athletic performance and leads toinjuries. It is very difficult to detect hypothermia because thesymptoms are completely vague such as loss of orientation and clumsinesswhich are indistinguishable from general behavior. Without measuringcore temperature and having an alert system when the temperature fallsoutside safe levels it is impossible to prevent hypothermia due to thevague symptoms. The present invention can alert an individual abouthypothermia during skiing, scuba diving, mountain climbing and hiking.The present invention provides means to precisely inform when certaintemperature thresholds are met, either too high or too low temperature.

The present invention continuously monitors the brain temperature and assoon as a temperature spike or fever occurs it activates diagnosticssystems to detect the presence of infectious agents, which can be donelocally in the BTT site, or the infectious agents can be identified inother parts of the body such as the blood stream or the eyelid pocket.The present invention can be also coupled to drug dispensing devices forthe automated delivery of medications in accordance with the signalproduced at the BTT site including transcutaneous devices, iontophoresisor by injection using a pump.

The invention also includes a tool for family planning. The system candetect spike and changes in basal temperature and identify moment ofovulation and phases of the menstrual cycle. This allows a woman to planpregnancy or avoid pregnancy. This eliminates the need for invasivedevices used for monitoring time for artificial insemination not onlyfor humans but also animals. The invention can yet detect the start ofuterine contractions (parturition) and allow a safer birth for animals.Support structures can be equally used in the BTT of animals.

The present invention also includes Automated Climate control accordingto the value measured at the BTT. The temperature of the user controlsthe temperature in a car. When the body starts to warm up, the signalfrom the apparatus of the invention automatically activates the airconditioner according to the user settings, alternatively it activatesheat when the body is cold. This automation allows drivers toconcentrate on the road and thus can reduce the risk for car crashes. Itis understood that other articles that can affect body temperature canbe controlled by the present invention including vehicle seats.

Current vehicle climate control systems are dramatically overpoweredbecause they are designed to heat/cool the vehicle cabin air mass froman extreme initial temperature to a standard temperature within acertain period of time. Because people have different thermal needs forcomfort, there is a consistent manual change of the temperature settingsand said manual further increase consumption of energy. For instance,car temperature is set to remain at 73 F. Some people after 15 minutesmay feel that it is too cold and some people may feel it is too hot.Subsequently the passenger changes the setting to 77 and then feels hotafter another 10 minutes, and needs to manually change the set pointsagain, and the process goes on. In addition the needs differ for peopleof different age, people with diabetes and other diseases, and male andfemale.

Manual frequent adjusting of a vehicle's climate control may increasefuel consumption 20% and increase emissions of pollutants such as carbonmonoxide and nitrogen oxides.

The present invention provides an automated climate control in which thebrain temperature controls the air conditioner and vehicle seats whichmaximizes comfort and minimizes fuel consumption. The improved fueleconomy provided by the present invention protects the environment dueto less pollutants affecting the ozone layer; improves public health bydecreasing emission of toxic fumes, and increases driver's comfort andsafety by less distractions with manually controlling a car's climatecontrol.

Thermal environment inside transportation vehicles can be adjustedaccording to the temperature at the BTT site including contact sensormeasurement and non-contact sensor measurement such as an infraredsensor or thermal image. The temperature at the BTT adjusts any articleor device in the car that changes the temperature inside the cabinincluding air conditioner and heater, vehicle seats, doors, windows,steering wheels, carpets on the floor of the vehicle, and the like.Exemplarily, the temperature at the BTT site adjusts the amount ofthermal radiation going through a window of a vehicle, if the BTT sendsa signal indicating hot sensation then the windows for instance willdarken to prevent further heat from entering the car, and vice versa ifcold is perceived the window changing its light transmissibility toallow more heat waves to penetrate the vehicle's cabin. Any articletouching the body or in the vicinity of the body can be adapted tochange its temperature to achieve thermal comfort for the occupants ofthe vehicle.

Besides the support structures and thermal imaging systems described inthe present invention to monitor and adjust temperature of a cabin of atransportation vehicle, it is understood that a contact lens inside theeyelid pocket with a temperature sensor can also be adapted to adjustthe temperature inside the cabin of the vehicle. Exemplarytransportation vehicles include cars, trucks, trains, airplanes, ships,boats, and the like.

It is also understood that the sensing system can include sensors inother parts of the body working in conjunction with the temperaturesensor measuring temperature and/or thermal radiation at the BTT site.Thermal energy transfer from an article to an occupant of a vehicle canoccur by any of radiation, convection, and the like, and any mechanismto transfer deliver, or remove thermal energy can be adjusted based on atemperature signal measured at the BTT.

The present invention provides a more energy-efficient system to achievethermal comfort of the passengers in any type of transportation vehiclein existence or being developed with any type of sensor alone at the BTTsite or in conjunction with sensors in other parts of the body.

Likewise, automated climate control at home, work, or any confined areacan be achieved by activating the thermostat directly or via BlueToothtechnology based on the temperature measured at the BTT in accordancewith the present invention. Besides convenience and comfort, thisautomation allows saving energy since gross changes manually done in thethermostat leads to great energy expenditure.

It is understood that any body temperature measuring system can provideautomated climate control or adjust temperature of articles inaccordance with the principles of the present invention.

The present invention yet includes methods for reducing weight. Itincludes monitoring of temperature during programs for weight reductionbased on increasing body heat to reduce said weight. The system alertsathletes on a weight losing program to prevent injury or death byoverheating. The system can monitor temperature of people in sauna,steam rooms, spas and the like as part of weight reduction programs inorder to prevent injuries and enhance results.

Yet, methods to enhance memory and performance besides preserving healthis achieved by providing an automated mechanism to control ambienttemperature and surrounding body temperature based on the braintemperature measured by the present invention. Human beings spend aboutone third of their lives sleeping. Many changes in body temperatureoccur during sleep. All of the metabolism and enzymatic reactions in thebody are dependent on adequate level of temperature. The adequatecontrol of ambient temperature which matches the needs of bodytemperature such as during sleeping have a key effect on metabolism.Adequate ambient temperature and surrounding temperature of objectswhich matches body temperature allow not only for people to sleepbetter, but also to achieve improved efficiency of enzymatic reactionswhich leads to improved mental ability and improved immune response. Avariety of devices such as blankets, clothing, hats, mattress, pillows,or any article touching the body or in the vicinity of the body can beadapted to automatically increase or decrease temperature of saidarticles according to the temperature signal from the present invention.

The body naturally becomes cooler during the night and many people haverestless sleep and turn continuously in bed because of that temperatureeffect. Since the tossing and turning occurs as involuntary movementsand the person is not awake, said person cannot change the stimuli suchas for instance increasing room temperature or increasing temperature ofan electric blanket. The present invention automatically changes theambient temperature or temperature of articles to match the temperatureneeds of the person. This is particularly useful for infants, elderly,diabetics, neuro-disorders, heart disease, and a variety of otherconditions, since this population has reduced neurogenic response tochanges in body temperature, and said population could suffer moreduring the night, have increased risk of complications besides decreasedproductivity due to sleep deprivation. Accordingly, the temperature ofan electrical blanket or the ambient temperature is adjustedautomatically in accordance with the temperature at the BTT. When lowtemperature at the BTT is detected by the apparatus of the invention awireless or wired signal is transmitted to the article to increase itstemperature, and in the case of an electrical blanket or heating system,the thermostat is automatically adjusted to deliver more heat.

The invention also provides devices and methods to be used with biofeedback activities. A brain temperature signal from the sensor at theBTT site produces a feedback signal as an audio tone or visual displayindicating temperature and a series of tones or colors identify if thebrain temperature is increasing (faster frequency and red) or decreasing(lower frequency and blue). The display devices can be connected bywires to the support structure holding the sensor at the BTT site.

Head cooling does not change brain temperature. Athletes, military,firefighters, construction workers and others are at risk of heatstrokedespite pouring cold water on their head or using a fan. Medicallyspeaking that is a dangerous situation because the cool feeling sensedin the head is interpreted as internal cooling and the physical activityis maintained, when in reality the brain remains at risk of thermalinduced damage and heatstroke. Other medical challenges related totemperature disturbances concern response time. The brain has a slowerrecovery response to temperature changes than core temperature (internaltemperature measured in rectum, bladder, esophagus, and other internalmechanisms). Thus, internal measurement may indicate stable temperaturewhile the brain temperature remains outside safe levels, with risk ofinduced damage to cerebral tissue, either due to hypothermia orhyperthermia. The only medically acceptable way to prevent cerebraltissue damage due to temperature disturbances is by continuousmonitoring brain temperature as provided by the present invention.

The present invention utilizes a plurality of active or passive sensorsincorporated in support structures for accessing a physiologic tunnelfor measuring biological parameters. The present invention preferablyincludes all functions in a miniature semiconductor chip, which as anintegrated circuit, incorporates sensor, processing and transmittingunits and control circuits.

Additional embodiments include temperature measurement and massscreening for fever and temperature disturbances (hyperthermia andhypothermia) comprising a body radiation detector, herein referred as aBTT ThermoScan, which comprises a thermal imaging system acquiring athermal image of the end of the BTT. The BTT ThermoScan of the presentinvention has sufficient temperature and isotherm discrimination formonitoring temperature at all times and without the possibility of themeasurement to be manipulated by artificial influences.

The BTT ThermoScan detects the brain temperature and provides an imagecorresponding to the BTT area or an image that includes the BTT area.

The BTT ThermoScan comprises a camera that converts thermal radiationinto a video image that can be displayed on a screen, such as the imagesseen in FIGS. 1A, 1B, 3A, 4A, 5A, 5C, 7A, 7B, 8A, 8B, 9A and 9B (foranimals), and most preferably the image seen in FIG. 1B. The radiantenergy emitted from the body and the BTT area is detected and imagedwithin the visible range.

Human skin at the BTT site has a high emissivity (e in theStefan-Boltzman formula) in the infrared range, nearly equal to a blackbody. A video image of people walking by and looking at the BTTThermoScan lens is captured and a customized software is adapted todisplay a colored plot of isotherm lines, as the software used toacquire the image of FIG. 1B in which any point at 99 degrees Fahrenheitis seen as yellow. For detection of SARS the software is adapted todisplay in yellow any point in the BTT area above 100 degreesFahrenheit. When the yellow color appears on the screen, the software isadapted to provide an automatic alarm system. Therefore when the BrainTemperature Tunnel area appears as yellow on the screen the alarm isactivated. It is understood that any color scheme can be used. Forinstance, the threshold temperature can be displayed as red color.

As shown in FIGS. 7A and 7B, cold challenge experiments were performedand demonstrated the stability of thermal emission in the BTT area. Thecold challenge consisted of continuous capturing thermal infrared imageswhile a subject is exposed to cold including facing a cold air generator(eg., air conditioner and fans), drinking cold liquids, body immersionin cold water, and spraying alcohol on the skin. Despite artificialmeans used to artificially change the body temperature the radiationfrom the BTT area remained intact, and can be seen as the bright whitespots in the BTT area. Contrary to that, the face gradually becamedarker indicating cooling of the face during the exposure to cold. FIG.7B shows a darker face compared to the face in FIG. 7A, but without anychange in the thermal radiation from the BTT area.

In addition to cold challenges, hot challenges was performed in order toartificially increase body temperature and included exercise, peoplewith sunburn, facing a heater, alcohol ingestion, cigarette smoking andbody immersion in hot water. In all of those experiments the BTT arearemained stable, but the remaining of the face had a change oftemperature reflecting skin temperature, not internal brain temperature.As seen in FIGS. 2A to 2C the brain is completely insulated from theenvironment, with the exception of the end of the BTT. The currenttechnology will have too many false positives and someone could bestopped at an airport or at customs just for drinking some alcohol orsmoking a cigarette, making the devices in the prior art ineffective.Therefore, the present invention provides a system and method thateliminates or reduces both false negatives and false positives whenusing thermal imaging detection systems.

Many useful applications can be achieved including mass screening forfever, screening for hyperthermia in athletes at the end of a sportsevent (e.g., marathon), screening for hypothermia or hyperthermia formilitary personnel so as to select the one best fit physiologically forbattle, and any other temperature disturbance in any condition in whicha BTT ThermoScan can be installed.

One particular application consists of prevention of a terrorist attackby a terrorist getting infected with a disease (e.g., SARS—Severe AcuteRespiratory Syndrome) and deceiving thermometers to avert detection offever when entering the country target for the terrorist attack.

SARS could potentially become a high terrorist threat because it cannotbe destroyed. By being naturally created, SARS could become a weapon ofmass destruction that cannot be eliminated despite use of military forceor diplomatic means. A terrorist can get the infection with the purposeof spreading the infection in the target country. With currenttechnology any device can be deceived and current devices would measurenormal temperature when indeed fever is present. Simple means can beused by a terrorist, such as washing their face with cold water or iceor by immersion in cold water, to manipulate any device in the prior artused for measuring fever including current infrared imaging systems andthermometers. The thermal physiology of the body, as it is measured andevaluated by the prior art, can be manipulated and the measurementperformed can give a false negative for fever.

A terrorist with SARS could easily spread the disease by many waysincluding individually by shaking hands with clerks on a daily basis ona mass scale by spending time in confined environments such as movietheater, a concert, grocery store, a government building, and others, orby contaminating water or drinking fountains. All of those peopleinfected do not know they caught the disease and start to spread SARS tofamily members, co-workers, friends and others, who subsequently willinfect others, leading to an epidemic situation.

From a medical standpoint, intentional spread of SARS can haveimmeasurable devastating effects. People not knowing they have thedisease may go to a hospital for routine checks or people not feelinggood may go to a hospital for routine checks. Patients and others comingto the hospital can then acquire the disease. Admitted patients, who aredebilitated, can easily acquire SARS. Spread of SARS in a hospitalenvironment can be devastating and the hospital may need to shut down.Therefore, one person with SARS can lead to the shut down of a wholehospital. Considering that people infected with the disease may go todifferent hospitals, several hospitals could get contaminated and wouldhave to be partially or completely shut down. This could choke thehealth care system of a whole area, and patients would have to betransported to other hospitals. Those patients may have acquired SARS aswell as perpetuating the transmission cycle. If this is done in severalareas by a concerted terrorist effort, much of the health care system ofa country could be choked, besides countless doctors and nurses couldbecome infected with SARS which would further cripple the health caresystem by shortage of personnel.

The key to prevent the catastrophic effects of a terrorist attack ispreparedness. The apparatus and methods of the present invention candetect SARS and cannot be manipulated by artificial means. Placement ofthe BTT ThermoScan of the present invention at the borders, ports andairports of a country can prevent the artificial manipulation of thetemperature measurement and a possible terrorist attack. The system ofthe present invention can identify at all times and under anycircumstances the presence of SARS and other diseases associated withfever.

In addition, mass screening of athletes could be performed with a BTTThermoScan installed at the finish line. An alert is activated for anyathlete who crosses the finish line with a high level of hyperthermia.Therefore immediate care can be delivered allowing for the best clinicaloutcome since any delay in identifying hyperthermia could lead toheatstroke and even death. The BTT ThermoScan is adapted to view atleast a portion of the BTT area. BTT ThermoScan detects the braintemperature and provides an image corresponding to or that includes theBTT area. Despite athletes pouring water on their head, the BTTThermoScan precisely detects the thermal status of the body by detectingthe temperature at the BTT.

Temperature disturbances such as hyperthermia and hypothermia can impairmental and physical function of any worker. Drivers and pilots inparticular can have reduced performance and risk of accidents whenaffected by temperature disturbances. The BTT ThermoScan can be mountedin the visor of a vehicle or plane to monitor body temperature with thecamera of the BTT ThermoScan capturing a thermal image of the BTT of thedriver or pilot and providing an alert whenever a disturbance isnoticed. It is understood that any thermal imaging system can be mountedin a vehicle or airplane to monitor body temperature and alert driversand pilots.

The BTT ThermoScan also includes monitoring mass screening of childrenand people at risk during flu season. With the shortage of nurses anautomated screening can greatly enhance the delivery of health care tothe ones in need. When a student walking by the infrared camera isidentified as having a temperature disturbance (e.g., fever) aconventional digital camera is activated and takes a picture of thestudent. The picture can be emailed to the school nurse that canidentify the student in need of care or automatically by using storeddigital pictures.

Hospitals, factories, homes, or any location that can benefit fromautomated mass or individual screening of temperature disturbances canuse the thermal imaging apparatus in accordance with the presentinvention.

It is understood that an apparatus comprised of a radiation sourceemitting a wavelength around 556 nm at the BTT site can be used fordetermining the concentration of hemoglobin. The hemoglobin present inthe red blood cells at the terminal end of the BTT strongly absorbs the556 nm wavelength and the reflected radiation acquired by aphotodetector determines the amount of hemoglobin. Blood flow can beevaluated by knowing the amount with thermal radiation, the higheramount of the thermal radiation indicating higher blood flow inaccordance to a mathematical model.

Positioning of contact sensors, non-contact sensors, and thermal imagingcamera are facilitated by external visible anatomic aspects that may bepresent. The cerebral venous blood can be seen under the skin in themedial canthal area next to the corner of the eye. Therefore a methodfor measuring temperature includes the step of visually detecting theblue or bluish color of the skin at the BTT area and positioning thesensor on or adjacent to the blue or bluish area. For subjects of darkerskin, a distinctive feature of difference skin texture in the BTT areanext to the medial corner of the eye can be used as the reference formeasurement.

The present invention includes devices for collecting thermal radiationfrom a BTT site, devices for positioning temperature sensitive devicesto receive thermal radiation from the BTT site and devices forconverting said thermal radiation into the brain temperature. Thepresent invention also provides methods for determining braintemperature with said methods including the steps of collecting thethermal emission from the BTT site, producing a signal corresponding tothe thermal emission collected, processing the signal and reporting thetemperature level. The invention also includes devices and methods forproper positioning of the temperature sensor in a stable position at theBTT site.

It is also an object of the present invention to provide supportstructures adapted to position a sensor on the end of a tunnel on theskin to measure biological parameters.

It is an object of the present invention to provide apparatus andmethods to measure brain temperature including patches, adhesivesstrips, elastic devices, clips and the like containing sensorspositioned on a physiologic tunnel.

It is an object of the present invention to provide apparatus andmethods to measure brain temperature including thermal imaging systemscontaining infrared sensors sensing infrared radiation from the BTT.

It is an object of the present invention to provide multipurposeeyeglasses equipped with medial canthal pads containing sensorspositioned on a physiologic tunnel for measuring biological parameters

It is another object of the present invention to provide new methods andapparatus for measuring at least one of brain temperature, chemicalfunction and physical function.

It is yet an object of the invention to provide apparatus that fit onboth adults and children.

It is also an object of the invention to provide apparatus that reportthe signal produced at the tunnel by at least one of wired connection toreporting devices, wireless transmission to reporting devices and localreporting by audio, visual or tactile devices such as by vibrationincorporated in support structures.

It is yet another object of the present invention to provide apparatusthat allow the wearer to avoid dehydration or overhydration (waterintoxication).

It is a further object of the present invention to provide methods andapparatus that allows athletes and sports participants to increase theirperformance and safety.

It is yet an object of the present invention to provide supportstructure positioned sensors on a tunnel which can be worn at least byone of athletes during practice and competition, military duringtraining and combat, workers during labor and the general public duringregular activities.

It is another object of the present invention to increase safety andcomfort in vehicles by providing automated climate control and vehicleseat control based on the core temperature of the occupants of thevehicle.

It is an object of the present invention to provide methods andapparatus that act on a second device based on the level of thebiological parameter measured.

It is another object of the invention to provide methods and apparatusto preserve skin health, reduce risk of wrinkles and reduce the risk ofskin cancer by preventing sun damage by thermal radiation and alertingthe wearer when the temperature has reached certain thresholds.

It is also an object of the invention to provide methods and apparatusfor achieving controlled weight loss based on heat-based weight lossapproach.

It is also an object of the invention to provide methods and apparatusto alert athletes in a weight losing program based on increasing bodytemperature to prevent injury or death by overheating.

It is also an object of the invention to provide methods and apparatusthat allow monitoring fever and spikes of temperature.

It is also an object of the invention to provide a device for familyplanning by detecting time of ovulation.

It is a further object of the invention to provide methods and apparatusfor the delivery of medications in accordance with the signal producedat the tunnel.

It is yet an object of the invention to provide methods and apparatusthat enhance occupational safety by continually monitoring biologicalparameters.

It is also an object of the invention to provide an article ofmanufacture with a sensing apparatus positioned on a tunnel formonitoring biological parameters that can be fitted or mounted in atleast one of the frame of eyeglasses, the nose pads of eyeglasses, thestructure of a head mounted gear and clothing.

The invention also features transmitting the signal from the supportstructure to act on at least one of exercise equipment, bikes, sportsgear, protective clothing, footwear and medical devices.

It is yet an object of the invention to provide support structures thattransmit the signal produced at the tunnel to treadmills and otherexercise machines for keeping proper hydration and preventingtemperature disturbances of the user.

It is yet another object of the invention to provide apparatus andmethods for monitoring biological parameters by accessing a physiologictunnel using active or passive devices.

The invention yet features transmission of the signal from the supportstructures to watches, pagers, cell phones, computers, and the like.

These and other objects of the invention, as well as many of theintended advantages thereof, will become more readily apparent whenreference is made to the following description taken in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a thermal infrared image of the human face showing the braintemperature tunnel.

FIG. 1B is a computer generated thermal infrared color image of thehuman face showing the brain temperature tunnel.

FIG. 2A is a schematic diagram showing a physiologic tunnel.

FIG. 2B is a cross-sectional schematic diagram of the human head showingthe tunnel.

FIG. 2C is a coronal section schematic diagram showing the cavernoussinus of FIG. 2B.

FIG. 3A is a thermal infrared image of the human face showing thetunnel.

FIG. 3B is a schematic diagram of the image in FIG. 3A showing thegeometry at the end of the tunnel.

FIG. 4A is a thermal infrared image of the side of the human faceshowing a general view of the main entry point of the brain temperaturetunnel.

FIG. 4B is a schematic diagram of the image in FIG. 4A.

FIG. 5A is a thermal infrared image of the front of the human faceshowing the main entry point of the brain temperature tunnel.

FIG. 5B is a schematic diagram of the image in FIG. 5A.

FIG. 5C is a thermal infrared image of the side of the human face inFIG. 5A showing the main entry point of the brain temperature tunnel.

FIG. 5D is a schematic view of the image in FIG. 5C.

FIG. 6 is a schematic view of the face showing the general area of themain entry point of the tunnel and peripheral parts.

FIG. 6A is a schematic diagram showing the brain temperature tunnel andthe metabolic tunnel.

FIGS. 7A and 7B are thermal infrared images of the human face before andafter cold challenge.

FIGS. 8A and 8B are thermal infrared images of the human face ofdifferent subjects showing the tunnel.

FIGS. 9A and 9B are thermal infrared images of animals showing a tunnel.

FIG. 10 is a perspective view of a preferred embodiment showing a personwearing a support structure comprised of a patch with a passive sensorpositioned on the skin at the end of the tunnel in accordance with thepresent invention.

FIG. 11 is a perspective view of another preferred embodiment showing aperson wearing a support structure comprised of a patch with a passivesensor positioned on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 12A is a front perspective view of a person wearing a supportstructure comprised of a patch with an active sensor positioned on theskin at the end of the tunnel in accordance with the present invention.

FIG. 12B is a side schematic view showing the flexible nature of thesupport structure shown in FIG. 12A.

FIG. 13 is a schematic block diagram of one preferred embodiment.

FIG. 14 is a schematic diagram of one preferred embodiment of theinvention interacting with devices and articles of manufacture.

FIGS. 15A to 15E are schematic views showing preferred embodiments ofthe invention using indicators.

FIGS. 16A to 16C are perspective views of a preferred embodiment showinga person wearing support structures incorporated as patches.

FIG. 17 is a perspective view of another preferred embodiment showing aperson wearing a support structure incorporated as a clip with a sensorpositioned on the skin at the end of the tunnel in accordance with thepresent invention.

FIG. 18 is a perspective view of another preferred embodiment showing aperson wearing a support structure with a sensor positioned on the skinat the end of the tunnel and connected by a wire.

FIGS. 19A1, 19A2, 19B, 19C and 19D are schematic diagrams of preferredgeometry and dimensions of support structures and sensing devices.

FIGS. 20A to 20C are schematic diagrams of preferred dimensions of theouter edge of support structures in relation to the outer edge ofsensing devices.

FIGS. 21A and 21B are schematic diagrams of preferred positions ofsensing devices.

FIGS. 22A to 22C are perspective views of preferred embodiments showinga person wearing a support structure incorporated as a medial canthalpad with a sensor positioned on the skin at the end of the tunnel inaccordance with the present invention.

FIGS. 23A and 23B are perspective views of an alternative embodimentshowing a support structure comprised of modified nose pads with asensor positioned on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 24 is a perspective view of another preferred embodiment of supportstructure in accordance with the invention.

FIG. 25 is a perspective view of one preferred embodiment of supportstructure showing additional structures for including a sensor.

FIG. 26A is a rear perspective view of one preferred embodiment of asupport structure with a display device.

FIG. 26B is a front perspective view of one preferred embodiment of asupport structure with a display device.

FIG. 27 is an exploded perspective view of another preferred embodimentshowing a three piece support structure.

FIG. 28A is an exploded perspective view of one preferred embodiment ofsupport structure showing a removable medial canthal piece.

FIG. 28B is a rear perspective view of the removable medial canthalpiece of FIG. 28A.

FIG. 28C is a front perspective view of the removable medial canthalpiece of FIG. 28B.

FIG. 29 is a rear perspective view of one preferred embodiment of asupport structure incorporated as a clip-on for eyeglasses.

FIG. 30 is a perspective view of one alternative embodiment of a supportstructure with medial canthal pads that uses an adhesive backing forsecuring to another structure.

FIG. 31A is a top perspective view of one alternative embodiment of asupport structure with holes for securing medial canthal pads.

FIG. 31B is a magnified perspective view of part of the supportstructure of FIG. 31A.

FIG. 31C is a side perspective view of part of the support structure ofFIG. 31B.

FIG. 31D is a side perspective view of a medial canthal piece secured atthe support structure.

FIG. 32A is a perspective view of a person wearing a support structurecomprised of medial canthal caps secured on top of a regular nose pad ofeyeglasses.

FIG. 32B is a perspective view of the medial canthal cap of FIG. 32A.

FIG. 33A is an exploded perspective view of a medial canthal cap beingsecured to the nose pad.

FIG. 33B is a perspective view of the end result of the medial canthalcap secured to the nose pad.

FIG. 34 is a perspective view of a modified rotatable nose pad toposition a sensor on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 35 is a schematic view of another preferred embodiment of thepresent invention using spectral reflectance.

FIG. 36 is a schematic view of a person showing another preferredembodiment in accordance with the present invention using spectraltransmission.

FIG. 37 is a schematic cross-sectional view of another preferredembodiment of the present invention using thermal emission.

FIG. 38 is a side perspective view of an alternative embodiment usinghead mounted gear as a support structure.

FIG. 39 is a schematic diagram of a preferred embodiment for generatingthermoelectric energy to power the sensing system.

FIG. 40 is a perspective view of a preferred embodiment for animal use.

FIGS. 41A and 41B are perspective views of an alternative embodiment ofa portable support structure with a sensor positioned at the tunnel.

FIGS. 42A and 42B are schematic diagrams showing a non-contact sensor inaccordance with the present invention.

FIG. 43A to 43C are diagrams showing preferred embodiments for thediameter of the cone extension

FIGS. 44A and 44B shows alternative geometries and shapes of an end ofthe extension.

FIGS. 45A and 45B shows exemplary geometries and shapes for a supportstructure containing a contact sensor.

FIGS. 46A to 46D shows exemplary geometries and shapes for medialcanthal pads or modified nose pads.

FIG. 47 is a schematic block diagram showing a preferred embodiment ofthe infrared imaging system of the present invention.

FIGS. 48 to 51 are schematic views showing the infrared imaging systemof the present invention mounted in a support structure in differentlocations for screening people for temperature changes.

FIG. 52A is a schematic view showing the infrared imaging system of thepresent invention mounted in a vehicle.

FIG. 52B is a representation of an illustrative image generated with theinfrared imaging system of FIG. 52A.

FIG. 53 shows a flowchart illustrating a method used in the presentinvention.

FIGS. 54A and 54B are perspective views of a preferred embodimentcoupled to a head gear.

FIG. 55 is a perspective view of a preferred embodiment comprised of amask and an air pack.

FIGS. 56A and 56B are schematic diagrams showing a BTT entry pointdetection system in accordance with the present invention.

FIG. 57 is a schematic diagram showing an automated BTT entry pointdetection system.

FIGS. 58A to 58C are schematic views showing alternative supportstructures in accordance with the present invention.

FIG. 59 is a schematic diagram showing bidirectional flow of thermalenergy in the BTT.

FIGS. 60A to 60C show diagrammatic views of a preferred BTT thermalpack.

FIG. 61 is a schematic frontal view showing a preferred BTT thermal packin accordance with the present invention.

FIG. 62 is a schematic cross sectional view of a BTT thermal pack.

FIG. 63A is a schematic cross sectional view of a BTT thermal pack inits relaxed state.

FIG. 63B is a schematic cross sectional view of a BTT thermal pack ofFIG. 63A in its compressed state conforming to the BTT area.

FIG. 64A is a side cross-sectional schematic view of a head of a personwith a BTT thermal pack.

FIG. 64B is a frontal schematic view of the eye area with BTT thermalpack of FIG. 64A.

FIG. 65 shows a perspective view of a BTT thermal pack containing a rod866.

FIG. 66 shows a schematic view of another embodiment of dual bag BTTthermal pack.

FIG. 67A shows a frontal schematic view of a BTT thermal mask.

FIG. 67B shows a side cross-sectional schematic view of the BTT thermalmask of FIG. 67A.

FIG. 67C shows a perspective frontal view of the BTT thermal mask ofFIG. 67A on the face and on the BTT.

FIG. 68A shows a perspective frontal view of a BTT thermal packsupported by support structure comprised of eyewear.

FIG. 68B shows a perspective frontal view of a BTT thermal packsupported by support structure comprised of a clip.

FIGS. 69A to 69C show perspective views of a preferred BTT thermal pack.

FIG. 69D is a perspective view of a BTT thermal pack of FIG. 69Apositioned on the BTT.

FIG. 70 is a schematic diagram showing a hand held non-contact BTTmeasuring device.

FIGS. 71A to 71C are schematic diagrams showing hand held infrared BTTmeasuring devices.

FIG. 72 is a schematic diagram showing a hand held contact sensormeasuring device.

FIG. 73 is a schematic diagram showing heat transfer devices coupled toBTT measuring devices.

FIG. 74 is a perspective diagram showing preferred BTT measuring devicesfor animals.

FIGS. 75A to 75E are graphs showing thermal signatures.

FIGS. 76A and 76B are schematic diagrams showing an antenna arrangement.

FIGS. 77A to 77C are schematic diagrams showing a support structurecomprised of hook and loop fastener.

FIG. 78 is a schematic diagram showing a support structure comprised ofhook and loop fastener with attached lenses.

FIGS. 79A and 79B are perspective images of alternative supportstructures.

FIG. 80 is a schematic diagram showing a support structure of FIG. 79A.

FIGS. 81A and 81D are schematic diagrams of a preferred supportstructure.

FIGS. 81C and 81D are perspective diagrams showing a support structureof FIG. 81A.

FIG. 82 is a schematic diagram showing electrical arrangement of asupport structure comprised of eyewear.

FIG. 83 is a perspective view showing an automated climate controlsystem.

FIG. 84 is a perspective frontal view showing an nasal airway dilator asan extension of a patch of the present invention.

FIGS. 85A to 85C are schematic diagrams showing kits in accordance withthe present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In describing a preferred embodiment of the invention illustrated in thedrawings, specific terminology will be resorted to for the sake ofclarity. However, the invention is not intended to be limited to thespecific terms so selected, and it is to be understood that eachspecific term includes all technical equivalents which operate in asimilar manner to accomplish a similar purpose.

FIG. 1A shows a thermal infrared image of the human face showing aphysiologic tunnel. The figure shows an image of the end of the braintemperature tunnel (BTT) depicted as white bright spots in the medialcanthal area and the medial half of the upper eyelid. The end of the BTTon the skin has special geometry, borders, and internal areas and themain entry point is located on the supero-medial aspect of the medialcanthal area diametrically in position with the inferior portion of theupper eyelid and 4 mm medial to the medial corner of the eye. From therethe boundary goes down in the medial canthal area diametrically inposition with the medial corner of the eye and within 5 mm down from themedial corner of the eye, and proceeding up to the upper eyelid with thelateral boundary beginning at the mid-part of the upper eyelid as anarrow area and extending laterally in a fan-like shape with thesuperior boundary beginning in the mid-half of the upper eyelid.

The scale indicates the range of temperature found in the human face.The hottest spots are indicated by the brightest white spots and thecoldest areas are black. Temperature between the hottest and coldestareas are seen in different hues in a gray scale. The nose is cold (seenas black) since it is primarily composed of cartilage and bones, andconsequently has a lower blood volume. That is the reason why frostbiteis most common in the nose.

The surrounding periocular area of the upper and lower eyelids (seen asgray) is hotter because of high vascularization and the reduced amountof adipose tissue. The skin underneath the eyelids is very thin and doesnot have adipose tissue either. However, the other conditions necessaryto define a brain temperature tunnel are not present in this area.

The BTT requirements also include the presence of a terminal branch todeliver the total amount of heat, a terminal branch that is a directbranch from a vessel from the brain, a terminal branch that issuperficially located to avoid far-infrared radiation absorption byother structures, and no thermoregulatory arteriovenous shunts. Thus,the BTT, i.e., the skin area in the medial corner of the eye and uppereyelid, is the unique location that can access a brain temperaturetunnel. The skin around the eyelids delivers undisturbed signals forchemical measurements using spectroscopy and is defined as a metabolictunnel with optimal acquisition of signals for chemical evaluation, butnot for evaluation of the total radiant power of the brain.

FIG. 1B is a computer generated thermal infrared color plot image of thehuman face showing in detail the geometry and different areas of thebrain temperature tunnel and surrounding areas. Only few creatures suchas some beetles and rattle snakes can see this type of radiation, butnot humans. The infrared images make the invisible into visible. Thusthe geometry and size of the tunnel can be better quantified. The colorplot of the isothermal lines show the peripheral area of the tunnel inred and the central area in yellow-white with the main entry point atthe end of the BTT located in the supero-medial aspect of the medialcanthal area above the medial canthal tendon.

The main entry point is the area of most optimal signal acquisition. Theimage also shows the symmetry of thermal energy between the two BTTsites. Since other areas including the forehead do not have theaforementioned six characteristics needed to define a BTT, said areashave lower total radiant power seen as light and dark green. Thus theforehead is not suitable to measure total radiant power. The whole nosehas very little radiant power seen as blue and purple areas, and the tipof the nose seen as brown has the lowest temperature of the face. Thus,the nose area is not suitable for measuring biological parameters.

FIG. 2A is a schematic diagram of a physiologic tunnel, moreparticularly a Brain Temperature Tunnel. From a physical standpoint, theBTT is a brain thermal energy tunnel characterized by a high totalradiant power and high heat flow and can be characterized as a BrainThermal Energy tunnel. The tunnel stores thermal energy and provides anundisturbed path for conveying thermal energy from one end of the tunnelin the cavernous sinus inside of the brain to the opposite end on theskin with the thermal energy transferred to the surface of the skin atthe end of the tunnel in the form of far-infrared radiation. High heatflow occurs at the end of tunnel which is characterized by a thininterface, and the heat flow is inversely proportional to the thicknessof the interface.

The total radiated power (P) at the end of the tunnel is defined byP=σ*e*A*T⁴, where σ is the Stefan-Boltzman constant with a valueσ=5.67×10⁻⁸ W·m⁻²·K⁻⁴ and e is the emissivity of the area. Since the endof the tunnel provides an optimal area for radiation, the total powerradiated grows rapidly as the temperature of the brain increases becauseof the T⁴ term in the equation. As demonstrated in the experiments inthe present invention mentioned, the radiated power in the BTT occurredat a faster rate than the radiated power in the tongue and oral cavity.

The BTT site on the skin is a very small area measuring only less than0.5% of the body surface area. However, this very small skin region ofthe body provides the area for the optimal signal acquisition formeasuring both physical and chemical parameters.

FIG. 2A shows the brain 10 with the thermal energy 12 stored in itsbody. The BTT 20 includes the brain 10, the thermal energy 12 stored inthe brain 10, the thermal energy stored in the tunnel 14 and the thermalenergy 16 transferred to the exterior at the end of the tunnel. Thethermal energy 12, 14, 16 is represented by dark arrows of same size andshape. The arrows have the same size indicating undisturbed thermalenergy from one end of the tunnel to the other and characterized byequivalent temperature within the tunnel.

Thermal energy from the sinus cavernous in the brain 10 is transferredto the end of the tunnel 16 and a rapid rate of heat transfer occursthrough the unimpeded cerebral venous blood path. The tunnel also has awall 18 representing the wall of the vasculature storing the thermalenergy with equivalent temperature and serving as a conduit from theinside of the body 10 to the exterior (skin surface) 19 which ends as aterminal vessel 17 transferring the total amount of thermal energy tosaid skin 19.

The skin 19 is very thin and allows high heat flow. The thickness ofskin 19 is negligible compared to the skin 39, 49 in non-tunnel areas 30and 40 respectively. Due to the characteristics of skin 19, high heatflow occurs and thermal equilibrium is achieved rapidly when a sensor isplaced on the skin 19 at the end of the BTT 20.

In other areas of skin in the face and in the body in general, and inthe exemplary non-tunnel areas 30 and 40 of FIG. 2 several interferingphenomena occur besides the lack of direct vasculature connection to thebrain, and includes self-absorption and thermal gradient. 1.Self-absorption: This relates to the phenomena that deep layers oftissue selectively absorb wavelengths of infrared energy prior toemission at the surface. The amount and type of infrared energyself-absorbed is unknown. At the surface those preferred emissions areweak due to self-absorption by the other layers deriving disorderedthermal emission and insignificant spectral characteristic of thesubstance being analyzed being illustratively represented by the varioussize, shapes and orientations of arrows 34 a to 36 g and 44 a to 46 g ofFIG. 2. Self-absorption in non-tunnel areas thus naturally preventsuseful thermal emission for measurement to be delivered at the surface.2. Thermal gradient: there is a thermal gradient with the deeper layersbeing warmer than the superficial layers, illustratively represented bythicker arrows 36 d and 46 d in the deeper layers compared to thinnerarrows 36 e and 46 e located more superficially. There is excessive andhighly variable scattering of photons when passing through variouslayers such as fat and other tissues such as muscles leading to thermalloss.

Contrary to that, the tunnel area 20 is homogeneous with no absorptionof infrared energy and the blood vessels are located on the surface.This allows undisturbed delivery of infrared energy to the surface ofthe skin 19 and to a temperature detector such as an infrared detectorplaced in apposition to said skin 19. In the BTT area there is nothermal gradient since there is only a thin layer of skin 19 withterminal blood vessel 17 directly underneath said thin interface skin19. The thermal energy 16 generated by the terminal blood vessel 17exiting to the surface skin 19 corresponds to the undisturbed brain(true core) temperature of the body. The preferred path for achievingthermal equilibrium with brain tissue temperature is through the centralvenous system which exits the brain and enters the orbit as the superiorophthalmic vein. The arterial blood is 0.2 to 0.3 degrees Celsius lowerwhen compared to the central venous blood, and said arterial blood isnot the actual equivalent of the brain temperature. Thus althougharterial blood may be of interest in certain occasions, the venoussystem is the preferred carrier of thermal energy for measurement ofbrain temperature. Arterial blood temperature may be of interest todetermine possible brain cooling by the arterial blood in certaincircumstances.

Non-tunnel areas 30 and 40 are characterized by the presence of heatabsorbing elements. The non-tunnel areas, 30 and 40 are defined bybroken lines characterizing the vulnerability of interference by heatabsorbing constituents and by the disorganized transferring of heat insaid non-tunnel areas 30 and 40. Various layers and other constituentsin non-tunnel areas 30 and 40 selectively absorb infrared energy emittedby the deeper layers before said energy reaches the surface of skin, andthe different thermal energy and the different areas are represented bythe different shapes and sizes of arrows and arrow heads.

Non-tunnel area 30 can be representative of measuring temperature with asensor on top of the skin anatomically located above the heart 32. Whitearrows 34 represent the thermal energy in the heart 32. Non-tunnel area30 includes the heart 32 and the various blood vessels and its branches36 a, 36 b, 36 c, 36 d storing thermal energy.

Different amounts of heat are transferred and different temperaturesmeasured depending on the location and anatomy of blood vessels 36 a, 36b, 36 c. The blood vessels branch out extensively from the main trunk 34a. The non-tunnel area 30 also includes heat absorbing structures 37such as bone and muscles which thermal energy 34 from the heart 32 needto be traversed to reach the skin 39. The non-tunnel area 30 alsoincludes a variable layer of fat tissue 38 which further absorbs thermalenergy. The reduced amount of thermal energy reaching the skin surfacedue to the presence of fat 38 is represented by the arrows 36 d and 36e, in which arrow 36 d has higher temperature than arrow 36 e.Non-tunnel area 30 also includes a thick skin 39 with low heat flowrepresented by arrows 36 f.

The thick skin 39 corresponds to the skin in the chest area and fatlayer 38 corresponds to the variable amount of fat present in the chestarea. Arrows 36 g represent the disordered and reduced total radiantpower delivered after said thermal energy traverses the interferingconstituents in the non-tunnel area including a thick interface and heatabsorbing structures. In addition, BTT 20 has no fat layer as found innon-tunnel areas 30 and 40. Lack of a thick interface such as thick skinand fat, lack of thermal barriers such as fat, and lack of heatabsorbing elements such as muscles allows undisturbed emission ofradiation at the end of the BTT. Lack of a thick interface such as thickskin and fat, lack of thermal barriers such as fat, and lack of heatabsorbing elements such as muscles allowed undisturbed emission ofradiation at the end of the BTT.

Yet referring to FIG. 2, non-tunnel area 40 can be representative ofmeasuring temperature with a sensor on top of the skin in the arm 42.The heat transfer in non-tunnel area 40 has some similarity withnon-tunnel area 30 in which the end result is a disordered and reducedtotal radiant power not representative of the temperature at theopposite end internally. The blood vessels branch out extensively fromthe main trunk 44 a. Thermal energy and temperature in blood vessels 46a, 46 b, 46 c is different than in areas 36 a, 36 b, 36 c. Thestructures that thermal energy 44 needs to traverse to reach the skinare also different compared to non-tunnel 30. The amount of heatabsorbing structures 47 is different and thus the end temperature atnon-tunnel 40 is also different when compared to non-tunnel area 30. Theamount of fat 48 also varies which changes the energy in areas 46 d and46 e, wherein area 46 d is deeper than area 46 e. Thick skin 49 alsoreduces heat flow and the temperature of the area 46 f. Reduction ofradiant power indicated by arrow 46 g when compared to radiant power 36g is usually quite different, so different skin temperature is measureddepending on the area of the body. This applies to the whole skinsurface of the body, with the exception of the skin at the end of theBTT.

Measurements of internal temperature such as rectal do not have the sameclinical relevance as measurement in the brain. Selective brain coolinghas been demonstrated in a number of mammalian species under laboratoryconditions and the same process could occur in humans. For instance thetemperature in bladder and rectum may be quite different than the brain.High or low temperature in the brain may not be reflected in thetemperature measured in other internal organs.

FIG. 2B is a cross-sectional schematic diagram of the human head 9showing the brain 10, spinal cord 10 a, the tunnel 20 represented by thesuperior ophthalmic vein, the cavernous sinus 1, which is the thermalenergy storage compartment for the brain, and the various insulatingbarriers 2, 2 a, 3, 4, 4 a, 4 b, 5 that keep the brain as a completelythermally insulated structure. Insulating barriers include skin 2corresponding to the scalp, skin 2 a corresponding to the skin coveringthe face, fat 3 covering the whole surface of the skull and face, skullbone 4, spinal bone 4 a surrounding spinal cord 10 a, facial bone 4 bcovering the face, and cerebral spinal fluid (CSF) 5. The combinedthickness of barriers 2, 3, 4, 5 insulating the brain can reach 1.5 cmto 2.0 cm, which is a notable thickness and the largest single barrieragainst the environment in the whole body. Due to this completelyconfined environment the brain cannot remove heat efficiently and heatloss occurs at a very low rate. Skin 2 corresponds to the scalp which isthe skin and associated structure covering the skull and which has lowthermal conductivity and works as an insulator. Fat tissue 3 absorbs themajority of the far-infrared wavelength and works as a thermal buffer.Skull bone 4 has low thermal conductivity and the CSF works as aphysical buffer and has zero heat production.

The heat generated by metabolic rate in the brain corresponds to 20% ofthe total heat produced by the body and this enormous amount of heat iskept in a confined and thermally sealed space. Brain tissue is the mostsusceptible tissue to thermal energy induced damage, both high and lowlevels of thermal energy. Because of the thermal insulation and physicalinability of the brain to gain heat or lose heat, both hypothermic(cold) and hyperthermic (hot) states can lead to brain damage and deathcan rapidly ensue, as occur to thousands of healthy people annuallybesides seizures and death due to high fever in sick people. Unlessappropriate and timely warning is provided by continuously monitoringbrain temperature anyone affected by cold or hot disturbances is at riskof thermal induced damage to the brain.

FIG. 2B also shows a notably small entry point 20 a measuring less than0.5% of the body surface which corresponds to the end of the tunnel 20on the skin 2 b. The skin 2 b is extremely thin with a thickness of 1 mmor less compared to the skin 2 and 2 a which are five fold or more,thicker than skin 2 b.

The tunnel 20 starts at the cavernous sinus 1 which is a conduit forvenous drainage for the brain and for heat transfer at the end of thetunnel 20 as a radiant energy. Tunnel 20 provides an unobstructedpassage to the cavernous sinus 1, a structure located in the middle ofthe brain, and which is in direct contact with the two sources of heatto the brain: 1) thermal energy produced due to metabolic rate by thebrain and carried by the venous system; and 2) thermal energy deliveredby the arterial supply from the rest of the body to the brain. Thisdirect contact arrangement is showed in detail in FIG. 2C, which is acoronal section of FIG. 2B corresponding to the line marked “A”.

FIG. 2C is a coronal section through the cavernous sinus 1 which is acavity-like structure with multiple spaces la filled with venous bloodfrom the veins 9 and from the superior ophthalmic vein 6. Cavernoussinus 1 collects thermal energy from brain tissue 7, from arterial bloodof the right and left internal carotid arteries 8 a, 8 b, and fromvenous blood from vein 9. All of the structures 7, 8 a, 8 b, 9 aredisposed along and in intimate contact with the cavernous sinus 1. Aparticular feature that makes the cavernous sinus 1 of the tunnel a veryuseful gauge for temperature disturbances is the intimate associationwith the carotid arteries 8 a, 8 b. The carotid arteries carry the bloodfrom the body, and the amount of thermal energy delivered to the brainby said vessels can lead to a state of hypothermia or hyperthermia. Forinstance during exposure to cold, the body is cold and cold blood fromthe body is carried to the brain by internal carotid arteries 8 a, 8 b,and the cavernous sinus 1 is the entry point of those vessels 8 a, 8 bto the brain.

As soon as cold blood reaches the cavernous sinus 1 the correspondingthermal energy state is transferred to the tunnel and to the skinsurface at the end of the tunnel, providing therefore an immediate alerteven before the cold blood is distributed throughout the brain. The sameapplies to hot blood for instance generated during exercise which canlead to a 20 fold heat production compared to baseline. This heatcarried by vessels 8 a, 8 b is transferred to the cavernous sinus 1 andcan be measured at the end of the tunnel. In addition, the thermalenergy generated by the brain is carried by cerebral venous blood andthe cavernous sinus 1 is a structure filled with venous blood.

FIG. 3A is a thermal infrared image of the human face in which thegeometry of the end of the tunnel on the skin can be visualized. Thewhite bright spots define the central area of the tunnel. FIG. 3B is aschematic diagram of an exemplary geometry on the skin surface at theend of the tunnel. The medial aspect 52 of the tunnel 50 has a roundshape. The lateral aspect 54 borders the upper lid margin 58 andcaruncle 56 of the eye 60. The tunnel extends from the medial canthalarea 52 into the upper eyelid 62 in a horn like projection.

The internal areas of the tunnel 50 include the general area for themain entry point and the main entry point as shown in FIGS. 4A to 5D.FIG. 4A is a thermal infrared image of the side of the human faceshowing a general view of the main entry point of the brain temperaturetunnel, seen as white bright points located medial and above the medialcanthal corner. FIG. 4B is a diagram showing the general area 70 of themain entry point and its relationship to the eye 60, medial canthalcorner 61, eyebrow 64, and nose 66. The general area 70 of the mainentry point provides an area with more faithful reproduction of thebrain temperature since the area 70 has less interfering elements thanthe peripheral area of the tunnel.

FIG. 5A is a thermal infrared image of the front of the human face withthe right eye closed showing the main entry point of the braintemperature tunnel seen as white bright spots above and medial to themedial canthal corner. With closed eyes it is easy to observe that theradiant power is coming solely from the skin at the end of BTT.

FIG. 5B is a diagram showing the main entry point 80 and itsrelationship to the medial canthal corner 61 of closed eye 60 andeyelids 62. The main entry point 80 of the tunnel provides the area withthe most faithful reproduction of the brain temperature since the area80 has the least amount of interfering elements and is universallypresent in all human beings at an equivalent anatomical position. Themain entry point 80 has the highest total radiant power and has asurface with high emissivity. The main entry point 80 is located on theskin in the superior aspect of the medial canthal area 63, in thesupero-medial aspect of the medial canthal corner 61.

FIG. 5C is a thermal infrared image of the side of the human face inFIG. 5A with the left eye closed showing a side view of the main entrypoint of the brain temperature tunnel, seen as bright white spots. Itcan be observed with closed eyes that the radiant power is coming solelyfrom the skin at the end of BTT.

FIG. 5D shows the main entry point 80 in the superior aspect of themedial canthal area above the medial canthal corner 61, and also showsthe position of main entry point in relation to the eye 60, eyebrow 64and nose 66. Support structures can precisely position sensing deviceson top of the main entry point of the tunnel because the main entrypoint is completely demarcated by anatomic landmarks. In general thesensor is positioned on the medial canthal skin area above the medialcanthal corner and adjacent to the eye. Although indicators can beplaced on support structures to better guide the positioning of thesensor, the universal presence of the various permanent anatomiclandmarks allows the precise positioning by any non-technical person.

The main entry point is the preferred location for the positioning ofthe sensor by the support structure, but the placement of a sensor inany part of the end of the tunnel including the general entry point areaand peripheral area provides clinically useful measurements depending onthe application. The degree of precision needed for the measurement willdetermine the positioning of the sensor. In cases of neurosurgery,cardiovascular surgery, or other surgical procedures in which thepatient is at high risk of hypothermia or malignant hyperthermia, thepreferred position of the sensor is at the main entry point. Forrecreational or professional sports, military, workers, fever detectionat home, wrinkle protection in sunlight, and the like, positioning thesensor in any part of the end of the tunnel area provides the precisionneeded for clinical usefulness.

In accordance with the present invention, FIG. 6 is a schematic view ofthe face showing the general area of the main entry point of the tunnel90 and the overall area of the end of the tunnel and its relationship tothe medial canthal tendon 67. The end of the tunnel includes the generalmain entry point area 90 and the upper eyelid area 94. The area 90 has aperipheral portion 92. Both medial canthal areas have a medial canthaltendon and the left eye is used to facilitate the illustration. Themedial canthal tendon 67 arises at the medial canthal corner 61 of eye60. The left medial canthal tendon 67 is diametrically opposed to theright medial canthal tendon as shown by broken lines 61 a which beginsat the medial corner of the eye 61. Although the main entry point isabove the medial canthal tendon 67, some of the peripheral area 92 ofthe tunnel is located below tendon 67.

FIG. 6A is a schematic diagram showing two physiologic tunnels. Theupper figure shows the area corresponding to the BTT 10. The lowerfigure shows an area corresponding to a metabolic tunnel 13 whichincludes the upper eyelid area 13 a and lower eyelid area 13 b seen aslight blue areas in FIG. 1B. For measuring the concentration of chemicalsubstances the total radiant power is not mandatory. The key aspect forclinical useful spectroscopic measurements is signal coming from thecerebral area and the reduction or elimination of interferingconstituents, and the main interfering constituent is adipose tissue. Byremoving adipose tissue and receiving spectral information carried by avasculature from the brain, precise and clinical measurements can beachieved. The sensors supported by support structure are adapted to havea field of view that matches in total or in part the metabolic tunnel 13for capturing thermal radiation from said tunnel 13.

To determine the thermal stability of the tunnel area in relation toenvironmental changes, cold and heat challenge tests were performed.FIGS. 7A and 7B are thermal infrared images of an exemplary experimentshowing the human face before and after cold challenge. In FIG. 7A theface has a lighter appearance when compared to FIG. 7B which is darkerindicating a lower temperature. The nose in FIG. 7A has an overallwhitish appearance as compared to the nose in FIG. 7B which has anoverall darker appearance. Since the areas outside the tunnel havethermoregulatory arteriovenous shunts and interfering constituentsincluding fat, the changes in the temperature of the environment arereflected in said areas. Thus measurements in those non-tunnel areas ofthe face reflect the environment instead of the actual body temperature.The non-tunnel areas of the skin in the face and body can change withthe changes in ambient temperature. The radiant power of the tunnel arearemains stable and there is no change in the amount of thermal energydemonstrating the stability of the thermal emission of the BTT area.Changes of thermal radiation at the tunnel area only occur when thebrain temperature changes, which provides the most reliable measurementof the thermal status of the body.

FIGS. 8A and 8B are thermal infrared images of the human face ofdifferent subjects showing the tunnel seen as bright white spots in themedial canthal area. The physiologic tunnel is universally present inall individuals despite anatomic variations and ethnic differences.FIGS. 9A and 9B are thermal infrared image showing that the tunnel seenas bright white spots are equally present in animals, illustrated hereby a cat (FIG. 9A) and a dog (FIG. 9B).

A preferred embodiment includes a temperature sensor with measurementprocessing electronics housed in a patch-like support structure whichpositions a passive sensor directly in contact with the skin over thebrain temperature tunnel site. Accordingly, FIG. 10 is a perspectiveview of a preferred embodiment showing a person 100 wearing a supportstructure comprised of a patch 72 with a passive sensor 74 positioned onthe skin at the end of the tunnel. Person 100 is laying on a mattress 76which contains antenna 78. Wire 82 extends from antenna 78 to controllerunit 84 with said controller 84 communicating with device 88 bycommunication line 86. Exemplary device 88 includes a decoding anddisplay unit at the bedside or at the nursing station. It is understoodthat controller unit 84 besides communicating by cable 86, can alsocontain a wireless transmission device to wirelessly transmit the signalacquired to a remote station. This inductive radio frequency poweredtelemetry system can use the same antenna 78 to transfer energy and toreceive the signal.

The antenna 78 can be secured to a mattress, pillow, frame of a bed, andthe like in a removable or permanent manner. The preferred embodimentincludes a thin flat antenna encapsulated by a flexible polymer that issecured to a mattress and is not visible to the user. Alternatively anantenna can be placed in any area surrounding the patient, such as on anight stand.

The antenna 78 and controller unit 84 works as a receiver/interrogator.A receiver/interrogator antenna 78 causes RF energy to radiate to themicrocircuit in the patch 72. This energy would be stored and convertedfor use in the temperature measurement process and in the transmissionof the data from the patch 72 to the antenna 78. Once sufficient energyhas been transferred, the microcircuit makes the measurement andtransmits that data to the receiver/interrogator antenna 78 with saiddata being processed at controller 84 and further communicated to device88 for display or further transmission. The switching elements involvedin the acquisition of the sensor data (measurement of the energy) isdone in a sequence so that the quantitized answer is available andstored prior to the activation of the noise-rich transmission signal.Thus the two inherently incompatible processes successfully coexistbecause they are not active simultaneously.

The capability of the RF link to communicate in the presence of noise isaccomplished by “spreading” the spectral content of the transmittedenergy in a way that would inherently add redundancy to the transmissionwhile reducing the probability that the transmission can ever beinterpreted by the receiver/interrogator 78 as another transmission ornoise that would cause the receiver/interrogator 78 to transmit anddisplay incorrect information. This wireless transmission scheme can beimplemented with very few active elements. The modulation purposelyspreads the transmission energy across the spectrum and thus providesnoise immunity and the system can be ultimately produced via batchprocessing and thus at a very low cost.

Since the energy to operate sensor 74 in patch 72 comes from the antenna78, the microcircuit in said patch 72 can be very small and ultra-thin.Size of the patch 72 would be further minimized to extremely smalldimensions by the design approach that places all the processingfunction of the RF link in the controller unit 84 working as a receiver.RF messaging protocol and the control of the sensor 74 resides in thereceiver/interrogator controller powered by commercially availablebatteries or by AC current. Thus the RF messaging protocol and thecontrol of the sensor 74 is directly controlled by the MCU of controller84. The circuit resident in the patch 72 is preferably completelyself-contained. The sensing system 74 in the patch 72 is preferably asilicon microcircuit containing the circuits needed to support thesensor, quantatize the data from the sensor, encode the data for radiofrequency transmission, and transmit the data, besides powerconditioning circuits and digital state control. Sensor, supportcircuitry, RF power and communications are all deposited on a micro-chipdie allowing the circuit to be built in large quantities and at very lowcost. This scheme is preferably used for both passive and activedevices.

The operational process can consist of two modes, manual or automated.In the manual mode, an operator such as a nurse activates the system andRF energy radiated to the microcircuit in the patch 72 would be storedand converted for use in the temperature measurement process and in thetransmission of the data from the end of the BTT to the antenna 78. Oncesufficient energy has been transferred (less than 1 second) themicrocircuit would make the measurement and transmit the data to theantenna 78 receiver and controller 84 to be displayed for example on aback-lit LCD display at the nursing station. An audio “beep” will signalthat the data had been received and is ready for view. In the automatedmode, the process is done automatically and continuously byinterrogation at preset frequency and an alarm being activated when thereading is outside the specified range. A tri-dimensional antenna canalso be used and the controller 84 set up to search the three dimensionsof the antenna to assure continued and proper connection between antenna78 and sensing means 74. It is also understood that the sensor canmodulate reflected RF energy. Accordingly, the energy will trigger theunit to acquire a temperature measurement, and then the unit willmodulate the reflected energy. This reflected energy and informationwill be received at the interrogator and displayed as above.

The present invention also provides a method for monitoring biologicalparameters, which comprises the steps of: securing a passive sensor tothe body; generating electromagnetic radiation from a device secured toat least one of a mattress, a pillow and the frame of a bed; generatinga signal from said passive sensor; receiving said signal by a devicesecured to at least one of a mattress, a pillow and the frame of a bed;and determining the value of the biological parameter based on saidsignal.

It is understood that a variety of external power sources such aselectromagnetic coupling can be used including an ultra-capacitorcharged externally through electromagnetic induction coupling and cellsthat can be recharged by an external oscillator. It is also understoodthat the sensing system can be remotely driven by ultrasonic waves.

FIG. 11 is a perspective view of another preferred embodiment showing incloser detail a person 100 wearing a support structure comprised ofpatch 72 with a sensor 74, transmitter 71, and digital converter andcontrol 73 positioned on the skin at the end of the tunnel. Person 100is wearing a necklace which works as antenna 78 and a pendant in thenecklace works as the controller unit and transmitting unit 79. Solarcells and/or specialized batteries power unit 79. Patients are used tocarrying Holter monitoring and cards with cords around their necks andthis embodiment can fit well with those currently used systems. It isunderstood that, besides a necklace, a variety of articles includingclothing and electric devices can be used as a receiver/interrogator andthis capability can be easily incorporated into cell phones, note bookcomputers, hand held computers, internet appliances for connecting tothe internet, and the like, so a patient could use his/her cell phone orcomputer means to monitor his/her brain temperature.

The preferred embodiments shown in FIGS. 10 and 11 can preferablyprovide continuous monitoring of fever or temperature spikes for anysurgery, for any patient admitted to a hospital, for nursing homepatients, in ambulances, and to prevent death or harm by hospitalinfection. Hospital infection is an infection acquired during a hospitalstay. Hospital infection is the fourth cause of death in the U.S. andkills more than 100,000 patients annually and occurs primarily due tolack of early identification of fever or temperature spikes. The presentinvention provides timely identification and therapy of an infection dueto 24 hour automated monitoring of temperature. If there is a spike intemperature an alarm can be activated. This will allow timelyidentification and treatment of an infection and thus prevent death orcostly complications such as septic shock that can occur due to delay intreating infectious processes. Besides, said preferred embodimentsprovide means for continuous fever monitoring at home including duringsleeping for both children and adults.

FIG. 12A is a front perspective view of a preferred embodiment showing aperson 100 wearing a support structure comprised of a patch 109 withindicator lines 111 and containing an active sensor 102 positioned onthe skin at the end of the tunnel. The preferred embodiment shown inFIG. 12 provides a transmitting device 104, a processing device 106, ADconverter 107 and a sensing device 102 connected by flexible circuit 110to power source 108. For example the transmitting module can include RF,sound or light. FIG. 12B is a side schematic view showing the flexiblenature of the support structure in FIG. 12A with flexible circuit 110connecting microelectronic package 103 which contains a transmittingdevice means, a processing device and a sensing device in the right sideof the patch 109 and the power source 108 in the left side of said patch109. Exemplary embodiments will be described.

In accordance with this exemplary embodiment for temperaturemeasurement, the thermal energy emitted by the BTT is sensed by thetemperature sensor 102 such as a miniature thermistor which produces asignal representing the thermal energy sensed. The signal is thenconverted to digital information and processed by processor 106 usingstandard processing for determining the temperature. An exemplarysonic-based system for brain temperature measurement comprises atemperature sensor, input coupling circuit, signal processing circuit,output coupling circuit and output display circuit. A temperature sensor102 (e.g., thermistor) in a patch 109 placed on the surface of the skinat the medial canthal area responds to variations in brain temperaturewhich is manifested as a DC voltage signal.

This signal, coupled to a Signal Processor Circuit via an Input CouplingCircuit is used to modulate the output of an oscillator, e.g., amultivibrator circuit, piezoelectric systems operating in or just abovethe audio frequency range. The oscillator is a primary component of theSignal Processor Circuit. The output of the oscillator is input to anamplifier, which is the second primary component of the SignalProcessor.

The amplifier increases the output level from the oscillator so that theoutput of the Signal Processor is sufficient to drive an Output DisplayCircuit. Depending on the nature of the Output Display Circuit, e.g., anaudio speaker, a visual LED display, or other possible displayembodiment, an Output Coupling Circuit is utilized to match the signalfrom the Signal Processor Circuit to the Output Display Circuit. For anOutput Display Circuit that requires a digital input signal, the OutputCoupling Circuit might include an analog to digital (A/D) convertercircuit. A DC power supply circuit is the remaining primary component inthe Signal Processor Module. The DC power supply is required to supportthe operation of the oscillator and the amplifier in the SignalProcessing Circuit. Embodiments of the DC power supply can include ultraminiature DC batteries, a light sensitive DC power source, or somecombination of the two, and the like. The micro transducers, signalprocessing electronics, transmitters and power source can be preferablyconstructed as an Application Specific Integrated Circuit or as a hybridcircuit alone or in combination with MEMS (micro electrical mechanicalsystems) technology.

The thermistor voltage is input to a microcontroller unit, i.e., asingle chip microprocessor, which is pre-programmed to process thethermistor voltage into a digital signal which corresponds to thepatient's measured temperature in degrees C. (or degrees F) at the BTTsite. It is understood that different programming and schemes can beused. For example, the sensor voltage can be directly fed into themicrocontroller for conversion to a temperature value and then displayedon a screen as a temperature value, e.g., 98.6° F. On the other hand thevoltage can be processed through an analog to digital converter (ADC)before it is input to the microcontroller.

The microcontroller output, after additional signal conditioning, servesas the driver for a piezoelectric audio frequency (ultrasonic)transmitter. The piezoelectric transmitter wirelessly sends digitalpulses that can be recognized by software in a clock radio sizedreceiver module consisting of a microphone, low-pass audio filter,amplifier, microcontroller unit, local temperature display andpre-selected temperature level alert mechanism. The signal processingsoftware is pre-programmed into the microcontroller unit of thereceiver. Although the present invention provides means for RFtransmission in the presence of noise, this particular embodiment usinga microphone as the receiving unit may offer additional advantages inthe hospital setting since there is zero RF interference with the manyother RF devices usually present in said setting. The microcontrollerunit drives a temperature display for each patient being monitored. Eachtransmitter is tagged with its own ID. Thus one receiver module can beused for various patients. A watch, cell phone, and the like adaptedwith a microphone can also work as the receiver module.

In another embodiment the output of the microcontroller is used to drivea piezo-electric buzzer. The microcontroller output drives thepiezo-electric buzzer to alert the user of the health threateningsituation. In this design the output of the microcontroller may be fedinto a digital-to-analog converter (DAC) that transforms the digitaldata signal from the microcontroller to an equivalent analog signalwhich is used to drive the buzzer.

In yet another embodiment the output from the (DAC) is used to drive aspeech synthesizer chip programmed to output an appropriate audiowarning to the user, for instance an athlete at risk of heatstroke. Fora sensed temperature above 39 degrees Celsius the message might be:“Your Body temperature is High. Seek shade. Drink cold liquid. Rest.”For temperature below 36 degrees Celsius the message might be: “YourBody temperature is Low. Seek shelter from the Cold. Drink warm liquid.Warm up.”

In another embodiment the output is used to drive a light transmitterprogrammed to output an appropriate light signal. The transmitterconsists of an infrared light that is activated when the temperaturereaches a certain level. The light signal will work as a remote controlunit that activates a remote unit that sounds an alarm. This embodimentfor instance can alert the parents during the night when the child issleeping and has a temperature spike.

An exemplary embodiment of the platform for local reporting consists ofthree electronic modules mechanically housed in a fabric or plasticholder such as patch 109, which contain a sensor 102 positioned on theskin at the BTT site. The modules are: Temperature Sensor Module,Microcontroller Module, and Output Display Module in addition to abattery. An electronic interface is used between each module for theoverall device to properly function. The configuration of this systemconsists of a strip such as patch 109 attached to the BTT area by aself-adhesive pad. A thermistor coupled to a microcontroller drives anaudio frequency piezoelectric transmitter or LED. The system provideslocal reporting of temperature without a receiver. An audio tone orlight will alert the user when certain thresholds are met. The tone canwork as a chime or reproduction of human voice.

Another exemplary embodiment for remote reporting consists of fourelectronic modules: Sensor Module, Microcontroller Module, OutputTransmitter Module and Receiver/Monitor Module. From a mechanicalviewpoint the first three modules are virtually identical to the firstembodiment. Electronically the Temperature Sensor and MicroprocessorModules are identical to the previous embodiment. In this embodiment anOutput Transmitter Module replaces the previous local Output DisplayModule. Output Transmitter Module is designed to transmit wirelessly thetemperature results determined by the Microprocessor Module to aremotely located Receiver/Monitor Module. An electronic interface isused between each module for proper function. This device can beutilized by patients in a hospital or home setting. On a continuousbasis temperature levels can be obtained by accessing data provided bythe Receiver/Monitor Module.

A variety of temperature sensing elements can be used as a temperaturesensor including a thermistor, thermocouple, or RTD (ResistanceTemperature Detector), platinum wire, surface mounted sensors,semiconductors, thermoelectric systems which measure surfacetemperature, optic fiber which fluoresces, bimetallic devices, liquidexpansion devices, and change-of-state devices, heat flux sensor,crystal thermometry and reversible temperature indicators includingliquid crystal Mylar sheets. A preferred temperature sensor includesthermistor model 104JT available from Shibaura of Japan.

FIG. 13 shows a block diagram of a preferred embodiment of the presentinvention linking transmitter 120 to receiver 130. Transmitter 120preferably includes a chip 112 incorporating a microcontroller (MCU)114, a radio frequency transmitter (RF) 116 and a A/D converter 118 inaddition to a power source 122, amplifier (A) 124, sensor 126, andantenna 128, preferably built-in in the chip. Exemplary chips include:(1) rfPIC12F675F, (available from Microchip Corporation, Arizona, USA)this is a MCU+ADC+433 Mhz Transmitter (2) CC1010, available from ChipconCorporation of Norway.

Receiver 130 preferably includes a chip RF transceiver 132 (e.g., CC1000available from Chipcon Corporation), a microcontroller unit (MCU) 134,amplifier and filtering units (A/F) 136, display 138, clock 140, keypad142, LED 144, speaker 146, in addition to a power source 150 andinput/output units (I/O) 148 and associated modem 152, opticaltransceiver 154 and communication ports 156.

A variety of devices can be used for the transmission scheme besides thecommercially available RF transmitter chips previously mentioned. Onesimple transmission devices include an apparatus with a single channeltransmitter in the 916.48 MHz band that sends the temperature readingsto a bed side receiver as a frequency proportional to the reading. Thethermistor's resistance would control the frequency of an oscillatorfeeding the RF transmitter data input. If the duty cycle is less than1%, the 318 MHz band would be usable. Rather than frequency, a periodmeasurement technique can be used. The model uses a simple radiofrequency carrier as the information transport and modulating thatcarrier with the brain temperature information derived from atransduction device capable of changing its electrical characteristicsas a function of temperature (e.g.; thermistor). Either frequency oramplitude of the carrier would be modulated by the temperatureinformation so that a receiver tuned to that frequency could demodulatethe changing carrier and recover the slowly moving temperature data.

Another transmission technique suitable to transmit the signal from asensor in a support structure is a chirp device. This means that whenactivated, the transmitter outputs a carrier that starts at a lowerfrequency in the ISM band and smoothly increases frequency with timeuntil a maximum frequency is reached. The brain temperature informationis used to modify the rate of change of frequency of the chirp. Thereceiver is designed to measure the chirp input very accurately bylooking for two or more specific frequencies. When the first of thefrequencies is detected, a clock measures the elapsed time until thesecond frequency is received. Accordingly, a third, fourth, etc.,frequency could be added to aid in the rejection of noise. Sincevirtually all the direct sequence spread spectrum transmitters andfrequency hopping transmitters are spread randomly throughout their partof the ISM band, the probability of them actually producing the “right”sequence of frequencies at exactly the right time is remote.

Once the receiver measured the timing between the target frequencies,that time is the value that would represent the brain temperature. Ifthe expected second, third, or fourth frequency is not received by thereceiver within a “known” time window, the receiver rejects the initialinputs as noise. This provides a spread spectrum system by using a widespectrum for transmitting the information while encoding the informationin a way that is unlike the expected noise from other users of the ISMband. The chirp transmitter is low cost and simple to build and thebrain temperature transducer is one of the active elements that controlsthe rate of change of frequency.

Other preferred embodiments for local reporting include a sensor, anoperational amplifier (LM358 available from National SemicondutorCorporation) and a LED in addition to a power source. It is understoodthat the operational amplifier (Op Amp) can be substituted by a MCU andthe LED substituted by a piezoelectric component.

FIG. 14 is a schematic diagram showing the support structure 160 to asensor 158, and MCU 164 controlling and/or adjusting unit 162.Communication between MCU 164 and unit 162 is achieved by wires 168 orwirelessly 166. By way of example, but not by limitation, exemplaryunits 162 include climate control units in cars, thermostats, vehicleseats, furniture, exercise machines, clothing, footwear, medicaldevices, drug pumps, and the like. For example, MCU 164 is programmedwith transmit the temperature level to receiver unit 162 in the exercisemachine. MCU in the exercising machine unit 162 is programmed to adjustspeed or other settings in accordance with the signal generated by MCU164.

The preferred embodiment allows precise positioning of the sensingapparatus by the support structure on the BTT site. The supportstructure is designed to conform to the anatomical landmarks of the BTTarea which assures proper placement of the sensor at all times. Thecorner of the eye is considered a permanent anatomic landmark, i.e., itis present in the same location in all human beings. The BTT area isalso a permanent anatomic landmark as demonstrated by the presentinvention. To facilitate consistent placement at the BTT site, anindicator in the support structure can be used as shown in FIGS. 15A to15E.

FIG. 15A shows a Guiding Line 170 placed on the outside surface of thesupport structure 172. The Guiding Line 170 is lined up with the medialcorner of the eye 174. The sensor 176 is located above the Guiding Line170 and on the outer edge of the support structure 172, so once theGuiding Line 170 of the support structure 172 is lined up with themedial corner of the eye 174, the sensor 176 is positioned on the mainentry point of the tunnel. Thus the support structure 172 can beprecisely and consistently applied in a way to allow the sensor 176 tocover the BTT area at all times.

FIG. 15B shows a different design of the patch 172 but with the sameGuiding Line 170 lined up with the medial corner of the eye 174, thusallowing consistent placement of sensor 176 at the BTT site despite thedifference in design.

FIG. 15C is another preferred embodiment showing the sensor 176 lined upwith medial corner 174. Thus in this embodiment a Guiding Line is notrequired and the sensor 176 itself guides the positioning.

In FIG. 15D the MCU 175 and cell 177 of patch 172 are located outside ofthe BTT site while sensor 176 is precisely positioned at the BTT site.It is understood that any type of indicator on the support structure canbe used to allow proper placement in the BTT area including externalmarks, leaflets, cuts in the support structure, different geometry thatlines up with the corner of the eye, and the like.

FIG. 15E is another preferred embodiment showing the superior edge 176 aof sensor 176 lined up with medial corner 174 and located in theinferior aspect of the medial canthal area while microchip controller175 is located in the superior aspect of the medial canthal area.Support structure 172 has a geometric indicator 179 comprised of a smallrecess on the support structure 172. It is understood that a stripworking as support structure like an adhesive bandage can have the sideopposite to the sensor and hardware made with tear off pieces. Thesensor side is first attached to the skin and any excess strip can beeasily torn off. Two sizes, adult and children cover all potentialusers.

The material for the support structure working as a patch can be softand have insulating properties such as are found in polyethylene.Depending on the application a multilayer structure of the patch caninclude from the external side to the skin side the following:thinsulate layer; double foam adhesive (polyethylene); sensor(thermistor); and a Mylar sheet. The sensor surface can be covered bythe Mylar sheet, which in turn is surrounded by the adhesive side of thefoam. Any soft thin material with high thermal resistance and lowthermal conductivity can be preferably used as an interface between thesensor and the exterior, such as polyurethane foam (K=0.02 W/m·C). Anysupport structure can incorporate the preferred insulation material.

A preferred power source for the patch includes natural thermoelectricsas disclosed by the present invention. In addition, standard lightweightthin plastic batteries using a combination of plastics such asfluorophenylthiophenes as electrodes can be used, and are flexibleallowing better conformation with the anatomy of the BTT site. Anotherexemplary suitable power source includes a light weight ultra-thin solidstate lithium battery comprised of a semisolid plastic electrolyte whichare about 300 microns thick.

The system can have two modes: at room temperature the system is quietand at body temperature the system is activated. The system can alsohave an on/off switch by creating a circuit using skin resistance, soonly when the sensor is placed on the skin is the system activated. Thepatch can also have a built-in switch in which peeling off a conductivebacking opens the circuit (pads) and turn the system on. In addition,when removed from the body, the patch can be placed in a case containinga magnet. The magnet in the case acts as an off switch and transmissionis terminated when said patch is in the case.

FIG. 16A to 16C are perspective views of preferred embodiments showing aperson 100 wearing support structures 180 incorporated as patches. In apreferred embodiment shown in FIG. 16A, the support structure 180contains LED 184, cell 186, and sensor 182. Sensor 182 is positioned ata main entry point on the superior aspect of the medial canthal areaadjacent to the medial corner of the eye 25. LED 184 is activated when asignal reaches certain thresholds in accordance with the principles ofthe invention. FIG. 16B is another preferred embodiment showing a person100 wearing support structure 180 with sensor 182 positioned at thegeneral area of the main entry point of the tunnel with the superioredge 181 of support structure 180 being lined up with the corner of theeye 25. Support structure 180 contains an extension that rests on thecheek area 189 and houses transmitting means 183 for wirelesstransmission, processing means 185 and power source 187. FIG. 16C is anexemplary preferred embodiment showing person 100 wearing a two piecestructure 180 a comprised of support structure 180 b and housingstructure 180 c connected by wires 192, preferably a flexible circuit.Support structure 180 b contains the sensor 182 which is positioned atthe BTT site. Housing structure 180 c which can comprise an adhesivestrip on the forehead 21 houses processing device 183 a, transmittingdevice 183 b and power source 187 for transmitting the signal to unit194, for example a cell phone.

FIG. 17 is a schematic view of another preferred embodiment showing thesupport structure 180 with sensor 182 being held at the nose 191 by aclip 196. Support structure 180 extends superiorly to the forehead 193.Housing 195 of support structure 180 contains pressure attachment meanssuch as clip 196. Housing 197 on the forehead contains the transmittingdevice and power source. Clip 196 uses a spring based structure 196 a toapply gentle pressure to secure support structure 180 and sensor 182 ina stable position. Housing 197 can also have a LCD display 19. The LCD19 can have an inverted image to be viewed in a mirror by the user,besides LCD 19 can have a hinge or be foldable to allow properpositioning to allow the user to easily view the numerical valuedisplayed.

FIG. 18 is a perspective view of another preferred embodiment showing aperson 100 wearing a support structure 180 comprised of a patch withsensor 182 positioned on the skin at the end of the tunnel and connectedby a wire 199 to a decoding and display unit 200. Support structure 180has a visible indicator 170 lined up with the medial corner of the eye174. Wire 199 includes an adhesive tape 201 within its first 20 cm, andmost preferably adhesive tape connected to wire 199 is in the first 10cm of wire from sensor 182.

FIGS. 19A1 to 19D are schematic views of preferred geometry anddimensions of support structures 180 and sensing device 182. Specialgeometry and dimension of sensors and support structure is necessary forthe optimal functioning of the present invention. The dimensions anddesign for the support structure 180 are made in order to optimizefunction and in accordance with the geometry and dimensions of thedifferent parts of the tunnel.

FIG. 19A1 shows support structure 180 working as a patch. The patch 180contains sensor 182. The patch 180 may contain other hardware or solelythe sensor 182. Exemplary sensor 182 is a flat thermistor or surfacemount thermistor. The preferred longest dimension for the patch referredto as “z” is equal or less than 12 mm, preferably equal to or less than8 mm, and most preferably equal to or less than 5 mm. The shortestdistance from the outer edge of the sensor 182 to the outer edge of thepatch 180 is referred to as “x”. “x” is equal to or less than 11 mm,preferably equal to or less than 6 mm and most preferably equal to orless than 2.5 mm. For illustrative purposes the sensor 182 has unequalsides, and distance “y” corresponds to the longest distance from outeredge of the sensor to outer edge of the patch 180. Despite havingunequal sides, the shortest distance “x” is the determining factor forthe preferred embodiment. It is understood that the whole surface of thesensor 182 can be covered with an adhesive and thus there is no distancebetween the sensor and an outer edge of a support structure.

An exemplary embodiment for that includes a sensor in which the surfacetouching the skin at the BTT site is made with Mylar. The Mylar surface,which comprises the sensor itself, can have an adhesive in the surfacethat touches the skin. In this case, the support structure that caninclude a piece of glue or an adhesive may be constructed flush inrelation to the sensor itself. Accordingly in FIG. 19E support structure171 comprised of a piece of glue supports sensor 182 in position againstthe BTT area. Sensor 182 can include a Mylar, a thermistor, thermocoupleand the like, and the sensor 182 can be preferably at the edge of thesupport structure 171 such as a piece of glue or any support structure,and said sensor 182 can be preferably further insulated in its outersurface with a piece of insulating material 173, such as polyethylene.

As shown in FIG. 19A2, the sensor 182 has adhesive in its surface, to besecured to skin 11. The sensor then can be applied to the BTT site inaccordance with the principles of the invention. The preferred distance“x” equal to or less than 2.5 mm allows precise pinpoint placement ofsensor 182 at the main entry site of the tunnel and thus allows the mostoptimal signal acquisition, and it should be used for applications thatrequire greatest precision of measurements such as during monitoringsurgical procedures. Although a patch was used as support structure forthe description of the preferred dimensions, it is understood that thesame dimensions can be applied to any support structure in accordancewith the principle of the invention including clips, medial canthalpads, head mounted gear, and the like.

FIG. 19B is an exemplary embodiment of a round patch 180 with a flatsensor 182. Preferred dimensions “x” and “z” apply equally as for FIG.19A1. FIG. 19C is an exemplary embodiment of a patch 180 with abead-type sensor 182. Preferred dimensions “x” and “z” apply equally asfor FIG. 19A1. FIG. 19D is an exemplary embodiment of a supportstructure 180 with a sensor-chip 15. Sensor chip 15 comprises a sensorthat is integrated as part of a chip, such as an Application SpecificIntegrated Circuit (ASIC). For example sensor chip 15 includes sensor 15a, processor 15 b, and transmitter 15 c. Preferred dimension “x” applyequally as for FIG. 19A1. Other hardware such as power source 27 may behoused in the support structure 180 which can have a long dimensionreferred to as “d” that does not affect performance as long as thedimension “x” is preserved.

The support structure and sensor are adapted to match the geometry anddimensions of the tunnel, for either contact measurements or non-contactmeasurements, in which the sensor does not touch the skin at the BTTsite.

FIGS. 20A to 20C show the preferred dimensions “x” for any supportstructure in accordance with the present invention. The distance fromthe outer edge 180 a of the support structure to outer edges of sensor182 a is 11 mm, as shown in FIG. 20A. Preferably, the distance from theouter edge 180 a of support structure to outer edges of sensor 182 a is6 mm, as shown in FIG. 20B. Most preferably, the distance from the outeredge 180 a of the support structure to outer edges of sensor 182 a is2.5 mm, as shown in FIG. 20C.

Preferred positions of sensors 182 in relation to the medial corner ofthe eye 184 are shown in FIGS. 21A and 21B. Support structure 180positions sensor 182 lined up with medial corner 184 (FIG. 21B).Preferably, as shown in FIG. 21A, support structure 180 positions thesensor 182 above the medial corner 184.

The preferred embodiments of support structures incorporated as patchesand clips are preferably used in the hospital setting and in the healthcare field including continuous monitoring of fever or temperaturespikes. Support structures incorporated as medial canthal pads or headmounted gear are preferred for monitoring hyperthermia, hypothermia andhydration status of recreational athletes, professional athletes,military, firefighters, construction workers and other physicallyintensive occupations, occupational safety, and for preventing wrinkleformation due to thermal damage by sun light.

FIGS. 22A to 22C are perspective views of preferred embodiments showinga person 100 wearing support structures incorporated as a medial canthalpad 204 of eyeglasses 206. In a preferred embodiment shown in FIG. 22A,the medial canthal pad 204 contains sensor 202. Connecting arm 208connects medial canthal pad 204 to eyeglasses frame 206 next to regularnose pads 212. Sensor 202 is positioned on the superior aspect of themedial canthal area adjacent to the medial corner of the eye 210.

FIG. 22B is an exemplary preferred embodiment showing person 100 wearingsupport structure incorporated as medial canthal pads 204 with sensor202 integrated into specially constructed eyeglasses frame 216 andcontaining LEDs 228, 230. Connecting piece 220 which connects the leftlens rim 222 and right lens rim 224 is constructed and positioned at ahigher position than customary eyeglasses construction in relation tothe lens rim 222, 224. Due to the higher position of connecting piece220 and the special construction of frame 216, the upper edge 222 a ofleft lens rim 222 is positioned slightly above the eyebrow 226. Thisconstruction allows medial canthal pad 204 to be positioned at the BTTsite while LEDs 228,230 are lined up with the visual axis. Arm 232 ofmedial canthal pad 204 can be flexible and adjustable for properpositioning of sensor 202 on the skin at the BTT site and for movingaway from the BTT site when measurement is not required. The LED 228 isgreen and LED 230 is red, and said LEDs 228, 230 are activated when asignal reaches certain thresholds.

FIG. 22C is an exemplary preferred embodiment showing person 100 wearingsupport structure incorporated as medial canthal pads 204 with sensor202. Signal from sensor 202 is transmitted wirelessly from transmitter234 housed in the temple of eyeglasses 236. Receiving unit 238 receivesa signal from transmitter 234 for processing and displaying. Exemplaryreceiving units 238 include watch, cell phone, pagers, hand heldcomputers, and the like.

FIGS. 23A to 23B are perspective views of alternative embodimentsshowing support structures incorporated as a modified nose pad 242 ofeyeglasses 244. FIG. 23A is a perspective view showing eyeglasses 244containing a modified nose pad 242 with sensor 240 and processor 241,sweat sensor 246 and power source 248 supported by temple 250, andtransmitter 252 supported by temple 254, all of which are electricallyconnected. Modified nose pads 242 are comprised of oversized nose padswith a horn like extension 243 superiorly which positions sensor 240 ontop of the end of the tunnel.

FIG. 23B is a perspective view showing eyeglasses 256 containing anoversized modified nose pad 258 with sensor 240, sweat sensor 260supported by temple 262, and transmitter 264 supported by temple 266.Modified oversized nose pad 258 measures preferably 12 mm or more in itssuperior aspect 258 a and contains sensor 240 in its outer edge inaccordance with the dimensions and principles of the present invention.

Another preferred embodiment of the invention, shown in FIG. 24,provides goggles 268 supporting medial canthal pads 260 adapted toposition sensor 262, 264 at the tunnel site on the skin. As shown,goggles 268 also support transmitting device 261, power source 263,local reporting device 265 such as LED and an antenna 267 for remotereporting. Antenna 267 is preferably integrated as part of the lens rim269 of goggles 268.

As shown in FIG. 25, additional device related to the signal generatedby sensor 270 in medial canthal pad 272 include power switch 274, setswitch 276 which denotes a mode selector, transmitter 278 for wirelesstransmission of signals, a speaker 282, piezoelectric device 283, inputdevice 284 and processing device 286. The device 274, 276, 278, 282,284, and 286 are preferably supported by any portion of the frame ofeyeglasses 280. It is understood that a variety of devices, switches andcontrolling devices to allow storage of data, time and other multiplefunction switches can be incorporated in the apparatus in addition towires for wired transmission of signals.

FIG. 26A is a rear perspective view of one preferred embodiment showingsensors 299, 300 supported by medial canthal pads 290, 289 of eyeglasses292 and includes lens rim 297 and display 298 in addition to transmitter288, sweat sensor 294 and wires 296 disposed within temple 295 and lensrim 293 of said eyeglasses 292 and connected to display device 296.

FIG. 26B is a front perspective view of eyeglasses 292 including sweatsensor 294, transmitter 288 and wires 296 disposed within temple 295 andlens rim 293 of eyeglasses 292 and connected to a display device. Inthis embodiment sweat sensor 294 produces a signal indicating theconcentration of substances in sweat (e.g., sodium of 9 mmol/L) which isdisplayed on left side display 296 and sensor 300 supported by medialcanthal pad 290 produces a signal indicative of, for example, braintemperature of 98 degrees F. which is displayed on the right sidedisplay 298. Sweat sensor can be porous or microporous in order tooptimize fluid passage to sensors when measuring chemical components.

A variety of display devices and associated lenses for proper focusingcan be used including liquid crystal display, LEDs, fiber optic,micro-projection, plasma devices, and the like. It is understood that adisplay device can be attached directly to the lens or be an integralpart of the lens. It is also understood that a display device caninclude a separate portion contained in the lens rim or outside of thelens rim. Further, the two lenses and displays 296, 298 held within thelens rims 293, 297 can be replaced with a single unit which can beattached directly to the frame of eyeglasses 292 with or without the useof lens rim 293, 297.

FIG. 27 is a perspective view of another preferred embodiment showing athree piece support structure 304 and preferably providing a medialcanthal pad connecting piece 303 adapted as an interchangeableconnecting piece. This embodiment comprises three pieces. Piece 301comprises left lens rim 301 a and left temple 301 b. Piece 302 comprisesright lens rim 302 a and right temple 302 b. Piece 303 called the medialcanthal piece connector comprises the connecting bridge of eyeglasses303 a and the pad structure 303 b of eyeglasses. Pad piece 303 isparticularly adapted to provide medial canthal pads 306 for positioninga sensor 308 at the BTT site. In reference to this embodiment, the usercan buy three piece eyeglasses in accordance with the invention in whichthe connector 303 has no sensing capabilities, and it is thus a lowercost. However, the three piece eyeglasses 304 offers the versatility ofreplacing the non-sensing connector 303 by a connector 303 with sensingcapabilities. As shown in FIG. 27 connector 303 with medial canthal pads306 and sensor 308 includes also radio frequency transmitter 310 andcell 312. Therefore, connector 303 provides all the necessary hardwareincluding devices for sensing, transmitting, and reporting the signal.Any devices for attachment known in the art can be used includingpressure devices, sliding devices, pins, and the like.

Another preferred embodiment, as shown in FIG. 28A, provides a removablemedial canthal piece 314 supporting sensor 316. As shown, connectingbridge 320 of eyeglasses 318 are attached to medial canthal piece 314 ina releasable manner. Eyeglasses 318 further includes sweat sensor 322,324 supported by front part 311 and transmitting device 326 supported bytemple 313. Front part 311 of eyeglasses 318 defines a front browportion and extends across the forehead of the wearer and contains sweatsensor 322, 324. Sweat fluid goes through membranes in the sensor 322,324 and reaches an electrode with generation of current proportional tothe amount of analyte found in the sweat fluid.

FIG. 28B is a rear perspective view of the removable medial canthalpiece 314 showing visual reporting devices 323, 325 such as a green LEDand a red LED in left arm 328 and sensor 316 adapted to be positioned atthe end of the tunnel, and wire 326 for electrically connecting rightarm 329 and left arm 328 of medial canthal piece 314. FIG. 28C is afront perspective view of the removable medial canthal piece 314 showingpower source 330, transmitter 332 and sensor 316 in right arm 329 andwire 326 for electrically connecting right arm 329 and left arm 328 ofmedial canthal piece 314. Medial canthal piece 314 can be replaced by anon-sensing regular nose pad which would have the same size anddimension as medial canthal piece 314 for adequate fitting withconnecting bridge 320 of eyeglasses 318 of FIG. 28A. The removablemedial canthal piece can have, besides LED, a built-in LCD display fordisplaying a numerical value and/or RF transmitter. Therefore, theremovable medial canthal piece can have one or various reporting devicesintegrated as a single sensing and reporting unit.

FIG. 29 is a rear perspective view of one preferred embodiment of asupport structure incorporated as a clip-on 340 for eyeglasses andincludes attachment device 338 such as a hook or a magnet, transmittingdevice 342, processing device 344, power source 346, medial canthal pad348 mounted on a three axis rotatable structure 349 for properpositioning at the BTT site, and sensor 350. Clip-on 340 is adapted tobe mounted on regular eyeglasses and to fit the medial canthal pad 348above the regular nose pads of eyeglasses.

Sensing medial canthal pads can be preferably connected to attachmentstructure such as eyeglasses independent of the presence of specializedconnecting or attachment devices mounted in said eyeglasses such asgrooves, pins, and the like. This embodiment provides means for theuniversal use of sensing medial canthal pads in any type or brand ofattachment structure. FIG. 30 shows a front perspective view of medialcanthal pads 352 comprising an adhesive backing 354 for securing pad 352to an attachment structure such as eyeglasses or another supportstructure. Adhesive surface 354 is adapted to match an area ofeyeglasses that allow securing medial canthal pad 352 to saideyeglasses, such as for instance the area corresponding to regular nosepads of eyeglasses. Medial canthal pad 352 works as a completelyindependent unit and contains sensor 356, power source 358 and reportingdevice 360 electrically connected by wire 361,362. Reporting device 360includes local reporting with visual devices (e.g., LED), audio devices(e.g., piezoelectric, voice chip Or speaker) and remote reporting withwireless transmission.

FIG. 31A is a top perspective view of one alternative embodiment of asupport structure incorporated as eyeglasses 380 with holes 364, 365 inregular nose pads 366, 376 for securing specialized medial canthal pads.Eyeglasses 380 includes wire 368 disposed within the right lens rim 371of the frame of eyeglasses 380 with said wire 368 connecting transmitter370 housed inside the right temple 369 to nose pad 366. Eyeglasses 380further includes wire 363 mounted on top of left lens rim 365 with saidwire 363 connecting transmitter 372 mounted on top of the left temple374 to nose pad 376. FIG. 31B is a magnified perspective view of part ofthe support structure 380 with hole 365 in regular nose pad 376. FIG.31C is a side perspective view of regular nose pad 366 with hole 364.FIG. 31D is a side perspective view of a medial canthal piece 382secured to hole 364 of regular nose pad 366.

FIG. 32A is a perspective view of a person 100 wearing a supportstructure comprised of medial canthal caps 390 secured on top of aregular nose pad 392 of eyeglasses 394. FIG. 32B is a perspective rearview of the medial canthal cap 390 showing sensor 396, transmitter chip398 and opening 397 for securing cap 390 to nose pads.

FIG. 33A is a perspective view of a medial canthal cap 390 being securedto the nose pad 392. Medial canthal cap 390 contains sensor 396,transmitter chip 398 and opening 397. FIG. 33B is a perspective viewshowing the end result of the medial canthal cap 390 secured to the nosepad 392.

Special nose pads are provided by the present invention for properpositioning a sensor at the BTT site. FIG. 34 is a perspective view of amodified left side rotatable nose pad 400 adapted to position a sensoron the skin at the end of the tunnel and includes nose pad 402 withsensor 401, arm 404, house 406 which houses a gear that allows rotationof a nose pad as a dial for positioning sensor 401 on different regionsof the tunnel identified as 1 and 2. Position 1 places the sensor inline with the medial canthal corner and reaches the general area of themain entry point of the tunnel and position 2 places the sensor abovethe medial canthal corner right at the main entry point of the tunnel.This embodiment allows automated activation of the sensing system andtakes advantage of the fact that the nose bridge is cold as seen in FIG.1 (nose is dark) and FIG. 2 (nose is purple and blue). When the pad isin its resting position (“zero”), the sensor 401 rests in a cold placewith temperature of 35.7° C. corresponding to the regular position ofnose pads on the nose. In position “zero” the sensor is in Sleep Mode(temperature of 35.8° C. or less). Changing the sensor to a hot regionsuch as the general area (position 1) or the main entry point (position2) automatically activates the sensor which goes into Active Mode andstart sensing function.

It is understood that numerous special nose pads and medial canthal padscan be used in accordance with the principles of the invention includinga pivotal hinge that allows pads to be foldable in total or in part,self-adjusting pads using a spring, pivoting, sliding in a groove, andthe like as well as self-adjusting mechanisms which are adaptable toanatomic variations found in different races. It is understood that themodified nose pads are preferably positioned high in the frame, mostpreferably by connecting to the upper part of the lens rim or within 6mm from the upper edge of the lens rim.

A variety of materials can be used including materials withsuper-adherent properties to allow intimate apposition of sensingdevices to the BTT site. A variety of metallic wires exhibitingsuper-elastic properties can be used as the hinge assembly mechanism forallowing proper positioning of a sensing device with the BTT site.Medial canthal pads can be made of a flexible synthetic resin materialsuch as a silicon rubber, conductive plastic, conductive elastomericmaterial, metal, pliable material, and the like so that appropriateapposition to the BTT site at the medial canthal area and properfunctioning is achieved. It is also understood that the medial canthalpads can exhibit elastic and moldable properties and include materialwhich when stressed is able to remain in the stressed shape upon removalof the stress. Any type of rubber, silicone, and the like with shapememory can also be used in the medial canthal pads and modified nosepad.

By greatly reducing or eliminating the interfering constituents andproviding a high signal to noise ratio with a sensor adapted to capturethermal radiation from the BTT, the present invention provides thedevices needed for accurate and precise measurement of biologicalparameters including chemical components in vivo using optical devicessuch as infrared spectroscopy. Moreover, the apparatus and methods ofthe present invention by enhancing the signal allows clinical usefulreadings to be obtained with various techniques and using differenttypes of electromagnetic radiation. Besides near-infrared spectroscopy,the present invention provides superior results and higher signal tonoise ratio when using other forms of electromagnetic radiation such asfor example mid-infrared radiation, radio wave impedance, photoacousticspectroscopy, Raman spectroscopy, visible spectroscopy, ultravioletspectroscopy, fluorescent spectroscopy, scattering spectroscopy andoptical rotation of polarized light as well as other techniques such asfluorescent (including Maillard reaction, light induced fluorescence andinduction of glucose fluorescence by ultraviolet light), colorimetric,refractive index, light reflection, thermal gradient, Attenuated TotalInternal Reflection, molecular imprinting, and the like. A sensoradapted to capture thermal energy at the BTE (Brain Thermal Energy)tunnel site provides optimal means for measurement of biologicalparameters using electromagnetic devices. The BTE tunnel is the physicalequivalent to the physiologic BTT and is used herein to characterize thephysics of the tunnel. The geometry and dimension on the skin surfaceare the same for the BTT and BTE tunnel.

The following characteristics of the BTE tunnel allow optimal signalacquisition. Skin at the end of the BTE tunnel is thin. With a thickskin radiation may fail to penetrate and reach the substance to bemeasured. Skin at the BTE tunnel is homogenous with constant thicknessalong its entire surface. Random thickness of skin as occurs in otherskin areas prevent achieving the precision needed. The BTE tunnel has nofat. The intensity of the reflected or transmitted signal can varydrastically from patient to patient depending on the individual physicalcharacteristics such as the amount of fat. A blood vessel in the end ofthe BTE is superficial, terminal and void of thermoregulatory shunts. Inother parts of the skin the deep blood vessels are located deep and varygreatly in position and depth from person to person. The BTE tunnel hasno light scattering elements covering its end such as bone, cartilageand the like. Thermal radiation does not have to go through cartilage orbone to reach the substance to be measured. The end of the BTE tunnel onthe skin has a special but fixed geometry and is well demarcated bypermanent anatomic landmarks. In other skin surfaces of the body,inconsistency in the location of the source and detector can be animportant source of error and variability.

Far-infrared radiation spectroscopy measures natural thermal emissionsafter said emissions interact and are absorbed by the substance beingmeasured. The present invention provides a thermally stable medium,insignificant number of interfering constituents, and a thin skin is theonly structure to be traversed by the thermal emissions from the BTEtunnel before reaching the detector. Thus there is high accuracy andprecision when converting the thermal energy emitted by the BTE tunnelinto concentration of the substance being measured.

The natural spectral emission by BTE tunnel changes according to thepresence and concentration of chemical substances. The far-infraredthermal radiation emitted follow Planck's Law and the predicted amountof thermal radiation can be calculated. Reference intensity iscalculated by measuring thermal energy absorption outside the substanceof interest band. The thermal energy absorption in the band of substanceof interest can be determined via spectroscopic means by comparing themeasured and predicted values at the BTE tunnel site. The signal is thenconverted to concentration of the substance measured according to theamount of thermal energy absorbed.

A sensor adapted to view the BTE tunnel provides means for measuring asubstance of interest using natural brain far-infrared emissions emittedat the BTE tunnel site and for applying Beer-Lambert's law in-vivo.Spectral radiation of infrared energy from the surface of the BTE tunnelsite corresponds to spectral information of chemical substances. Thesethermal emissions irradiated at 38 degrees Celsius can include the 4,000to 14,000 nm wavelength range. For example, glucose strongly absorbslight around the 9,400 nm band. When far-infrared thermal radiation isemitted at the BTE tunnel site, glucose will absorb part of theradiation corresponding to its band of absorption. Absorption of thethermal energy by glucose bands is related in a linear fashion to bloodglucose concentration in the thermally sealed and thermally stableenvironment present in the BTE tunnel.

The support structure includes at least one radiation source frominfrared to visible light which interacts with the substance beingmeasured at the BTE tunnel and a detector for collecting the resultingradiation.

The present invention provides method for measuring biologicalparameters comprising the steps of measuring infrared thermal radiationat the BTE tunnel site, producing output electrical signalsrepresentative of the intensity of the radiation, converting theresulting input, and sending the converted input to a processor. Theprocessor is adapted to provide the necessary analysis of the signal todetermine the concentration of the substance measured and for displayingthe results.

The present invention includes means for directing preferablynear-infrared energy into the surface of the skin at the end of the BTEtunnel, means for analyzing and converting the reflectance or backscattered spectrun into the concentration of the substance measured andsupport structure for positioning the light source and detector deviceadjacent to the surface of the skin at the BTE tunnel site.

The present invention also provides methods for determining theconcentration of a substance with said methods including the steps ofdirecting electromagnetic radiation such as near-infrared at the skin atthe BTE tunnel site, detecting the near-infrared energy radiated fromsaid skin at the BTE tunnel site, taking the resulting spectra andproviding an electrical signal upon detection, processing the signal andreporting concentration of the substance of interest according to saidsignal. The invention also includes device and methods for positioningthe light sources and detectors in stable position and with stablepressure and temperature in relation to the surface to which radiationis directed to and received from.

The present invention further includes devices for directing infraredenergy through the nose using medial canthal pads, devices forpositioning radiation source and detector diametrically opposed to eachother, and devices for analyzing and converting the transmittedresulting spectrum into the concentration of the substance measured. Thepresent invention also provides methods for measuring biologicalparameters with said methods including the steps of directingelectromagnetic radiation such as near-infrared through the nose usingmedial canthal pads, collecting the near-infrared energy radiated fromsaid nose, taking the resulting spectra and providing an electricalsignal upon detection, processing the signal and reporting concentrationof the substance measured according to said signal. The invention alsoincludes means and methods for positioning the radiation sources anddetectors in a stable position and with stable pressure and temperaturein relation to the surface to which radiation is directed through.

The present invention yet includes devices for collecting naturalfar-infrared thermal radiation from the BTE tunnel, devices forpositioning a radiation collector to receive said radiation, and devicesfor converting the collected radiation from the BTE tunnel into theconcentration of the substance measured. The present invention alsoprovides methods for measuring biological parameters with said methodsincluding the steps of using the natural far-infrared thermal emissionfrom the BTE tunnel as the resulting radiation for measuring thesubstance of interest, collecting the resulting radiation spectra,providing an electrical signal upon detection, processing the signal andreporting the concentration of the substance measured according to saidsignal.

A drug dispensing system including an infusion pump can be activatedaccording to the level of the substance measured at the BTE tunnel, forexample insulin can be injected automatically as needed to normalizeglucose levels as an artificial pancreas.

Any substance present in blood which is capable of being analyzed byelectromagnetic devices can be measured at the BTE tunnel. For examplebut not by way of limitation such substances can include exogenouschemicals such as drugs and alcohol as well as endogenous chemicals suchas glucose, oxygen, lactic acid, cholesterol, bicarbonate, hormones,glutamate, urea, fatty acids, triglycerides, proteins, creatinine,aminoacids and the like. Values such as pH can also be calculated as pHcan be related to light absorption using reflectance spectroscopy.

In accordance with FIG. 35 a schematic view of one preferred reflectancemeasuring apparatus of the present invention is shown. FIG. 35 shows alight source 420 such as an infrared LED and a photodetector 422 locatedside-by-side and disposed within support structure 426 such as a medialcanthal pad or modified nose pads of eyeglasses directing radiation 424at the BTE tunnel 430 with said light source 420 laying in apposition tothe skin 428 at the BTE tunnel 430. The light source 420 delivers theradiation 424 to the skin 428 at the BTE tunnel which is partiallyabsorbed according to the interaction with the substance 432 beingmeasured resulting in attenuated radiation 425. Part of the radiation424 is then absorbed by the substance 432 and the resulting radiation425 emitted from BTE tunnel 430 is collected by the photodetector 422and converted by a processor into the blood concentration of thesubstance 432. Thin skin 428 is the only tissue interposed betweenradiation 424, 425 and the substance 432 being measured. Theconcentration of the substance 432 is accomplished by detecting themagnitude of light attenuation collected which is caused by theabsorption signature of the substance being measured.

Infrared LEDs (wavelength-specific LEDs) are the preferred light sourcefor this embodiment because they can emit light of known intensity andwavelength, are very small in size, low-cost, and the light can beprecisely delivered to the site. The light source 420 emits preferablyat least one near-infrared wavelength, but alternatively a plurality ofdifferent wavelengths can be used. The light source emits radiation 424,preferably between 750 and 3000 nm, including a wavelength typical ofthe absorption spectrum for the substance 432 being measured. Thepreferred photodetector includes a semiconductor photodiode with a 400micron diameter photosensitive area coupled to an amplifier as anintegrated circuit.

FIG. 36 shows a schematic view of a person 100 wearing a supportstructure 434 and light source 436 and detector 438 adapted to measurebiological parameters using spectral transmission device. The lightsource 436 and photodetector 438 are positioned diametrically opposed toeach other so that the output of the radiation source 436 goes throughthe nasal interface 442 containing the substance 440 being measuredbefore being received by the detector 438. Photodetector 438 collectsthe resulting transmitted radiation which was directed through the nasalinterface 442. A variety of LEDs and optical fibers disposed within thesupport structure 434 such as the medial canthal pads, nose pads andframes of eyeglasses are preferably used as a light delivery for thelight source 436 and the light detector 438.

Arms of support structures 434 such as medial canthal pads are moveableand can be adjusted into different positions for creating a fixed orchangeable optical path. Preferred substances measured include oxygenand glucose. The brain maintains constant blood flow, whereas flow inextremities change according to cardiac output and ambient conditions.The oxygen levels found in the physiologic tunnel reflects centraloxygenation. The oxygen monitoring in a physiologic tunnel isrepresentative of the general hemodynamic state of the body. Manycritical conditions such as sepsis (disseminated infection) or heartproblems which alter perfusion in most of the body can be monitored.Oxygen in the BTE tunnel can continuously monitor perfusion and detectearly hemodynamic changes.

FIG. 37 is a schematic cross-sectional view of another preferredembodiment of the present invention using thermal emission from the BTEtunnel. FIG. 37 shows a support structure 450 housing a thermal infrareddetector 444 which has a filter 446 and a sensing element 448 with saidsensing element 448 being preferably a thermopile and responding tothermal infrared radiation 452 naturally emitted by the BTE tunnel 454.The support structure 450 is adapted to have sensing device 448 with afield of view that corresponds to the geometry and dimension of the skin462 at the end of the BTE tunnel 454. Support structure 450 provideswalls 456, 458 which are in contact with the skin 462 with said wallscreating a cavity 460 which contains thermal radiation 453 which hasalready passed through thin skin 462.

For example in the thermally sealed and thermally stable environment inthe BTE tunnel 454, at 38° Celsius spectral radiation 453 emitted as9,400 nm band is absorbed by glucose in a linear fashion according tothe amount of the concentration of glucose due to thecarbon-oxygen-carbon bond in the pyrane ring present in the glucosemolecule. The resulting radiation 453 is the thermal emission 452 minusthe absorbed radiation by the substance 464. The resulting radiation 453enters the infrared detector 444 which generates an electrical signalcorresponding to the spectral characteristic and intensity of saidresulting radiation 453. The resulting radiation 453 is then convertedinto the concentration of the substance 464 according to the amount ofthermal energy absorbed in relation to the reference intensityabsorption outside the substance 464 band.

The same principles disclosed in the present invention can be used fornear-infrared transmission measurements as well as for continuous wavetissue oximeters, evaluation of hematocrit, blood cells and other bloodcomponents. The substance measured can be endogenous such as glucose orexogenous such as alcohol and drugs including photosensitizing drugs.

Numerous support structures can position sensors at the BTT site formeasuring biological parameters. Accordingly, FIG. 38 is a sideperspective view of an alternative embodiment showing a person 100 usinghead mounted gear 470 as a support structure positioning with wires 478and sensor 476 on the skin at the BTT site. A microelectronic package472 containing transmitting means, processing means, and power source isdisposed within or mounted on head band 470, with said head band 470providing wire 478 from microelectronic package 472 for connection withsensing device 476 on the skin at the BTT site.

It is understood that the sensing device can be an integral part of thesupport structure or be connected to any support structures such asusing conventional fasteners including screw, pins, a clip, atongue-groove relationship, interlocking pieces, direct attachment,adhesives, mechanical joining, and the like; and said support structuresinclude patches, clips, eyeglasses, head mounted gear, and the like.

Various means to provide electrical energy to the sensing system weredisclosed. The BTE tunnel offers yet a new way for natural generation ofelectrical energy. Accordingly, FIG. 39 is a schematic diagram of apreferred embodiment for generating thermoelectric energy from the BTEtunnel to power the sensing system. The generator of the inventionconverts heat from the tunnel into electricity needed to power thesystem. A thermoelectric module is integrated into the support structureto power the sensing system. The thermoelectric module preferablyincludes a thermopile or a thermocouple which comprises dissimilarmetallic wires forming a junction. As heat moves from the tunnel throughthe thermoelectric module an electric current is generated. Since theBTE tunnel is surrounded by cold regions, the Seebeck effect can providemeans for generating power by inducing electromotive force (emf) in thepresence of a temperature gradient due to distribution of electriccharges at the surface and interface of the thermoelectric circuitgenerated by the temperature at the BTE tunnel.

Accordingly, FIG. 39 shows the junctions T1 and T2 of metallic wire A470 and metallic wire B 472 kept at different temperatures by placingjunction T1 at the main entry point of the tunnel and junction T2 in acold area such as the nose bridge (denoted in blue or purple in FIG. 1B,and referred herein as blue-purple nose). Metallic wires A 470 and B 472are made of different materials and electric current flows from the hotto the cold region due to the thermal gradient with a magnitude given bythe ratio of the thermoelectric potential. The potential U is given byU=(Q_(a)−Q_(b))*(T₁−T₂), where Q_(a) and Q_(b) denote the Seebeckcoefficient (thermoelectric power) of metal A and metal B₂ and T₁denotes temperature at the entry point of the BTE tunnel and T₂ denotestemperature at the blue-purple nose. The thermoelectric potentialgenerated can power the sensing system and a capacitor 474 inserted intothe system can be used to collect and store the energy and MCU 476 isadapted to control the delivery of energy as needed for measuring,processing and transmitting the signal.

It is understood that other means to convert thermal energy from the BTEtunnel into electricity can be used. It is also understood that thesurface of the eye and caruncle in the eye can provide a thermalgradient and Seebeck effect, however it is much less desirable thanusing the skin at the end of the BTE tunnel since hardware and wirestouching the surface of the eye and/or coming out of the eye can bequite uncomfortable and cause infection. It is yet understood that thecold end can include any relatively cold article including the frame ofthe glasses as well as the air.

Contrary to that numerous support structures disclosed in the presentinvention including eyeglasses can easily be adapted to provide in anunobtrusive manner the power generating system of the invention, forexample by using a support structure such as eyeglasses for positioningthe hot junction at the BTE site using medial canthal pads andpositioning the cold junction on the nose using regular nose pads ofeyeglasses. It is also understood that although the power generatingsystem using Brain Thermal Energy was designed for powering the sensingsystem of the present invention, any other electrical device could beadapted to be supplied with energy derived from the Brain Thermal Energytunnel.

Additional embodiments include support structures to position the sensorat the BTT site of animals. Many useful applications can be achieved,including enhancing artificial insemination for mammalian species bydetecting moment of ovulation, monitoring herd health by continuousmonitoring of brain temperature, detection of parturition and the like.

Accordingly, FIG. 40 is a perspective view of a preferred embodimentshowing an animal 101 with sensor 480 positioned at the BTT site withwire 482 connecting sensor 480 with a microelectronic package 484containing a transmitting device, a processing device, and power sourcein the eyelid pocket 486 of animal 101. Signal from microelectronicpackage 484 is preferably transmitted as radio waves 489. The signalfrom the transmitter in package 484 can be conveyed to a GPS collarallowing the identification of the animal having a high temperatureassociated with the localization of said animal by GPS means. Wheneverthere is an increase in brain temperature identified by the sensingdevice 480, the signal of high temperature activates the GPS collar toprovide the localization of the affected animal. Alternatively theremote radio station receiving waves 489 activate the GPS system whenthe abnormal signal is received. In this case, the transmitter inpackage 484 only sends the signal to the remote station, but not to theGPS collar.

FIG. 41A is a perspective view of a portable support structure 490positioning sensor 492 in contact with the skin 494 at the BTT site formeasuring biological parameters. Support structure 490 incorporated as athermometer with a contact sensor 492 is held by a second person 17 forpositioning the sensor 492 on the skin 494 and performing themeasurement. FIG. 41B is a perspective view of a portable supportstructure 496 with walls 500 positioning non-contact sensor 498 such asa thermopile with a field of view that matches in total or in part thegeometry and dimension of the skin area at the end of the BTT. Supportstructure 496 incorporated as an infrared thermometer is held by asecond person 105 for positioning the sensor 498 and measuringbiological parameters. Although it is understood that pointing aninfrared detector to the BTT site can be used in accordance with theinvention, the temperature measured is not as clinically useful becauseof the ambient temperature. Therefore, the support structure 496contains walls 500 that create a confined environment for thermalradiation to reach sensor 498 from the skin over the tunnel. Walls 500of the support structure are adapted to match the geometry of the tunneland to provide a cavity 499 with the boundaries consisting of the sensorsurface 492 and the skin area 493 viewed by said sensor 498, in asimilar manner as described for FIG. 37.

Now, with reference to FIGS. 42A and 42B, FIG. 42A is a schematicdiagram showing the support structure 496, also referred to herein as ahousing, a window 502 and radiation sensor 504 contained in the housing496 and an extension 510 secured to the housing adapted for temperaturemeasurement at the BTT area. In a preferred embodiment, the extension510 has walls 500 and is substantially conical in shape and secured to ahousing 496 adapted to be held by a hand 105 as shown in FIG. 41B. Tomeasure the temperature, a user 105 positions the extension 510 adjacentto the BTT site such that the walls 500 of the extension 510 lie on theskin at the BTT area and the radiation sensor 504 views the BTT area.FIG. 42B is a schematic view showing the walls 500 of extension 510creating a cavity 499 wherein thermal radiation 506 emitted from theskin 508 at the BTT area 518 is received by the radiation sensor 504.BTT area 506 is surrounded by the thick skin and fat in non-BTT areas512. BTT temperature measurements are obtained from the output of theradiation sensor 504 contained in the housing 496. Electronics 514within the housing 496 convert the received radiation to a temperaturelevel which is displayed on a housing display 516 as illustrativelyshown in FIG. 41B.

The radiation sensor 504 views at least a portion of the BTT surfaceskin area 508 through an infrared radiation transparent window 502 anddetect infrared radiation 506 from the BTT skin surface 508. Theradiation sensor 504 is preferably a thermopile, but other radiationsensors may also be used such as pyroelectric detectors or any otherradiation sensors that detect heat flux from the surface beingevaluated. Exemplary window 502 materials include silicon and germanium.The sensor 504 is preferably mounted in an extension 510 which is shapedto match the dimension and geometry of the BTT area 508. The extension510 can easily be positioned such that only the skin area 508 at the endof the BTT 518 may be viewed by the radiation sensor 504 wherein theskin area 508 is at substantially the same temperature as the braintemperature. Once in a position for the sensor 504 to view the BTT skinarea 508, a button 522 is pressed to begin a measurement and theprocessing 514 within the housing 496 determines the brain temperatureand display the value in a liquid crystal display 516 coupled to a sounddevice 524 for emitting an audio signal. A disposable cover may be usedto cover any part of the apparatus in contact with the skin.

Although the temperature at the end of the BTT is substantiallyequivalent to the brain temperature based on the temperature of thecavernous sinus and cerebral blood, a variety of mathematicalcalculations and means can be used to determine the temperature at theBTT area including arterial heat balance, venous heat balance, andambient temperature. It is understood that the BTT detector can containa sensor for measuring ambient temperature and said measured ambienttemperature be used for calculating temperature of the subject.

The temperature at the BTT area can be used as a reference for adjustingmeasurement acquired in other parts of the body outside the BTT area.The electrical equivalent of the BTT tunnel is an area of high voltagebut low current, in which the voltage representing the temperature isvirtually equal at the two ends of the tunnel. The high perfusion in theend of the BTT keeps a high temperature at the skin at the end of saidend of the BTT.

The present invention also provides a method for detecting bodytemperature including the steps of providing a temperature detectorpositioned adjacent to the BTT during temperature detection anddetermining the temperature based on the radiation sensed at the BTTarea. It is understood that the detector can remain in one position ormove around the BTT area to identify the surface with the highesttemperature.

A further method of detecting body temperature includes the steps ofscanning a temperature detector across the BTT area and other areas inthe head or in the contra-lateral BTT area and selecting the highesttemperature, preferably selecting the highest temperature by scanningthe right and the left BTT areas with the processor in the BTT detectordetermining and selecting the highest temperature.

Another method for identifying the highest temperature point in the BTTarea can be found by scanning a radiation detector over the BTT area andhaving a processor adapted to select the highest reading and indicatethat with an audio signal. The temperature detector 20 provides anaudible beep with each peak reading.

FIG. 43A to 43C are diagrams showing preferred embodiments for thediameter of the cone extension 510 at the end of the housing 496 incontact with the skin 508 at the BTT site 518. It is understood thatalthough any shape can be used for the extension, the extension takespreferably the form of a cone with a radiation sensor positioned to viewthe BTT area. The cup 520 has an outer diameter at its end which isequal to or less than the BTT area. In FIG. 43A, for the radiationsensor 504 viewing the general area of the BTT site 508 the preferredouter diameter of the end 524 of the cup 520 is equal to or less than 13mm. In FIG. 43B for the radiation sensor 504 viewing the general mainentry point of the BTT site 508 the preferred outer diameter of the end524 of the cup is equal to or less than 8 mm. In FIG. 43C, for theradiation sensor 504 viewing the main entry point the preferred outerdiameter of the end 524 of the cup 520 is equal to or less than 5 mm. Itis understood that although the preferred geometry of the radiationsensor and extension is round and has a substantially conical shape, anyother shape of the radiation sensor and/or extension can be usedincluding oval, square, rectangular, and the like. It is understood thatthe diameter and geometry is preferably chosen to match the geometry ofthe BTT area. It is also understood that the dimension of the sensor 504is adapted to match the dimension of the cup 520 to the viewing area ofthe skin 508.

In accordance with a further aspect of the present invention, theextension is adapted to fit on top of the eyelids. The portion of theextension 510 of the housing 496 in contact with the skin 508 can alsohave an inner concave surface that matches the eyelid contour.Alternatively, the portion of the conical extension 510 in contact withthe skin 508 can have a convex surface to match the medial canthal areaand upper lid above the medial corner of the eye.

It is also understood that the dimensions for pediatric use are abouttwo thirds of the dimension for adult size, or even half or less thanhalf of adult size especially in small children. Accordingly, thepreferred sizes of the outer diameter of the extension for children are:for the radiation sensor viewing the general area the preferred outerdiameter of the extension is equal to or less than 9 mm for viewing thegeneral area of the BTT, equal to or less than 6 mm for viewing thegeneral main entry point of the BTT, and equal to or less than 4 mm forviewing the main entry point of the BTT.

Besides the preferred round shape for the end 524 of extension 510,FIGS. 44A and 44B shows alternative geometries and shapes of end 524extension 510 for non-contact sensor with said sensor viewing at least aportion of the BTT area next to the corner 528 of the eye 526. In FIG.44A, the outer shape of the end 524 of extension 510 is shown as an ovalshape. FIG. 44B shows an elliptical, banana or half moon shape of end524 of extension 510 for viewing the medial canthal area and the uppereye lid area.

FIGS. 45A and 45B shows exemplary geometries and shapes for a supportstructure containing a contact sensor with said sensor positioned on theskin at the BTT area. FIG. 45 is a schematic frontal view showing atemperature sensor 530 in the shape of a rod contained in a patch 532and positioned vertically on the BTT area 534 next to the corner of theeye 538 and nose 537 with a cord 536 extending from the distal end ofthe sensor 530. FIG. 45B is a side view of FIG. 45A showing sensor 530with cord 536 contained in patch 532 next to the eye 539. A sensor isplaced centrally in the patch, wherein the patch measures less than 11mm in diameter.

FIGS. 46A to 46D shows exemplary geometries and shapes for medialcanthal pads or modified nose pads and their relation to the medialcorner of the eye. FIG. 46A, shows a frontal view of a modified nose pad540 containing a sensor 542 located centrally in said nose pad 540wherein the sensor 542 is positioned on the skin at the BTT area next tothe corner of the eye 544 and nose 546. FIG. 46B is a side view showingthe eye 545 and nose 546 and the modified nose pad 540 with the sensor542 positioned at the BTT site. FIG. 46C show a frontal view of amodified nose pad 550 having a sensor 552 located in its outer edge andpositioned on the skin area at the BTT site next to the corner of theeye 554 and nose 556. FIG. 46D is a side view showing the eye 555 andnose 556 and the modified nose pad 550 with the sensor 552 positioned atthe BTT site. It is understood that although an extension is thepreferred embodiment with the sensor not contacting the skin, aninfrared sensor probe adapted to touch the skin at the BTT area can alsobe used.

Now in reference to the thermal imaging systems of the presentinvention, FIG. 47 is a schematic block diagram showing a preferredembodiment of the infrared imaging system of the present invention. FIG.47 shows a BTT ThermoScan 560 comprising a camera 562, a microprocessor564, a display 566, and a power source 568. The system further includesproprietary software and software customized for the precise measurementand mapping of the BTT area. The BTT ThermoScan 560 includes a camera562 with a lens 574, an optical system 572 that can contain mirrors,filters and lenses for optimizing image acquisition, and a photodetector570, also referred to herein as a radiation sensor or a radiationdetector, to quantify and record the energy flux in the far infraredrange. The display unit 566 displays the thermal image of the BTT beingviewed by the lens 574 in the camera. Radiation detector materials knownin the art can be used in the photodetector 570 including alloys ofindium-antimonide, mercury-cadmiun-telluride, Copper doped Germanium,Platinum Silicide, Barium Strontium Titanate, and the like.

The infrared radiation detector converts the incident radiation thatincludes the BTT area into electrical energy which is amplified. Thedetector 570 is responsive to infrared radiation to provide an outputsignal and discrete points related to the intensity of the thermalenergy received from the BTT area and the surrounding area around theBTT area.

The discrete points are imaged and each point source must have enoughenergy to excite the radiation detector material to release electrons.Any point size can be used, but preferably with a size between 1 and 2mm in diameter. When using an angle of 1.3 mrads, the BTT ThermoScan cancapture an instantaneous image from a point size of approximately 1 mmdiameter at a distance of 1 m from the detector. It is understood thatany spatial resolution for optimal capturing of the BTT image can beused, but it is preferably between 1.0 and 1.6 mrad. The camera 562 ofthe BTT ThermoScan 560 has a field of view adapted to view the BTT area.Discrete points are further converted into an image of the face thatincludes the BTT area in the medial corner of the eye and upper eyelid.The screening function of the BTT ThermoScan is based on the temperatureat the BTT area, either absolute temperature or the differentialtemperature of the BTT area in relation to a reference.

The electrical response to the thermal radiation can be displayed on themonitor as intensity, with a strong signal producing a bright (white)point as seen in FIG. 1A with said white point being representative ofthe highest radiant energy from the source. In FIG. 1A the source is thehuman face and the highest intensity of radiation is found in the BTTarea. Calibration of the display screen result in a continuum shades ofgray, from black (0 isotherm) to bright white (1 isotherm). Each pointis digitally stored for further processing and analysis.

It is understood that a variety of lenses, prisms, filters, Fresnellenses, and the like known in the art can be used to change the angle ofview or optimize signal acquisition and capture of thermal energy fluxfrom the face and the BTT area. The lens of the BTT ThermoScan 560 ispreferably perpendicular to the plane of the human face or of the BTTarea being viewed.

The radiation detector material in the BTT ThermoScan 560 is preferablysensitive to radiation with wavelength ranging from 8 to 12 μm. The BTTThermoScan 560 has a temperature span set between 2 to 5 degrees Celsiusand is extremely sensitive and adapted to discern temperatures to within0.008 degrees Celsius to 0.02 at a range of 1 meter. Temperaturemeasurements can be based on radiometric means with built-in electronicsor by differential using a reference such as a black body. Although thesystem can be uncooled, to maximize the efficiency of the detector andachieve an optimum signal to noise ratio the detector can be cooledusing solid state means, liquid nitrogen, evaporation of compressedargon gas, piezoelectric components, and the like.

Many radiation detectors capable of detecting infrared waves are beingdeveloped including silicon based, solid state systems, andmicrobolometers, and all said systems new or to be developed in thefuture can be used in the apparatus of the present invention to detectthermal radiation from the BTT with the display of a corresponding imageof the BTT in a monitor.

An exemplary infrared detector system includes a microbolometer which isfabricated on silicon substrates or integrated circuits containingtemperature sensitive resistive material that absorbs infraredradiation, such as vanadium oxide. The incident infrared radiation fromthe BTT area is absorbed by the microbolometer producing a correspondingchange in the resistance and temperature. Each microbolometer functionsas a pixel and the changes in electrical resistance generate anelectrical signal corresponding to thermal radiation from the BTT areathat can be displayed in a screen of a computer.

The display of the image of the BTT is the preferred embodiment of theinvention, but the present invention can be implemented without displayof an image. Radiation coming from the BTT can be acquired by theradiation sensors aforementioned and the temperature of the BTT area canbe calculated based on the electrical signal generated by the radiationsensor using a reference. Any means to detect thermal radiation and/ortemperature from the BTT area can be used in accordance with theprinciples of the invention.

Besides the easy manipulation of temperature at the skin level outsidethe BTT area, significantly lower temperatures are found in the areasoutside the BTT as shown in the image on the screen, and depicted in thephotos of FIGS. 1A and 1B. The lower and more unstable temperatureoutside the BTT area results in generating a non-clinically significanttemperature level or thermal image when said areas outside the BTT areused for sensing thermal radiation and/or measuring temperature.

It is understood that a variety of signal conditioning and processingcan be used to match the temperature areas outside the BTT area to avalue that corresponds to the BTT area, and those methods also fall inthe scope of the invention. Image outside the BTT area as seen more likea blur compared to the BTT area and superimposition of images thatinclude the BTT area can also be used for achieving higher level ofaccuracy during temperature measurements. Comparing a radiation patternoutside the BTT area with the BTT area without necessarily creating animage of the BTT area can also be used for accurate and precisetemperature measurement and evaluation of the thermal status of the bodyin accordance with the principles of the invention. Any method or deviceused for temperature evaluation or evaluation of the thermal status thatis based on the temperature level or thermal radiation present in theBTT area by generating or not generating an image falls within the scopeof the present invention.

FIG. 48 is a schematic view showing the thermal imaging system 560 ofthe present invention adapted to be used in an airport 580 including aninfrared camera 582, a processor 584, and a display 586 which aremounted in a support structure 588 at an airport 580. Camera 582 scansthe BTT area present in the medial corner of the eye 590 in a human face591 and provides an output signal to a signal processor 584. The outputsignal is an electronic signal which is related to the characteristic ofthe thermal infrared energy of the BTT 590 in the human face 591 whenpeople 592, 593 walking by look at or are viewed by the camera 582. Theprocessor 584 processes the output signal so that an image of the BTTarea 594 can be formed by the display 586 such as a computer monitor.

Exemplarily, passenger 592 is looking at the camera 582 for sensing thethermal radiation from the BTT area 590, with said passenger 582 holdinghis/her eyeglasses since for the camera 582 to precisely view the BTTarea 590 the eyeglasses have to be removed. If someone goes by thecamera 582 without a thermal image of the BTT 590 being acquired analarm will be activated. Likewise, if someone has a temperaturedisturbance an alert indicative of said temperature disturbance isactivated.

FIG. 49 is a schematic view showing the thermal imaging system 560 ofthe present invention adapted to be used in any facility that has agathering of people such as a movie theater, a convention, stadium, aconcert, a trade show, schools, and the like. In FIG. 49 the infraredcamera 596 of the BTT Thermoscan 560 is located at the entrance of theaforementioned facilities and while people 598 show their identificationor ticket to an agent 602, the BTT ThermoScan 560 scans the side of theface of the people 598 to capture a thermal image 600 and temperature atthe BTT tunnel which is displayed in a remote computer display 604. Thecamera 596 has adjustable height and a tracking system to track theheat, and therefore said camera 596 can position itself for sensingthermal radiation from people 598 at different distances and ofdifferent height. It is also understood that the BTT Thermoscan 560 canbe used in any facility including optical stores for adjustingpositioning of sensors in eyeglasses.

A facility that is of strategic importance such as a governmentbuilding, military bases, courts, certain factories and the like canalso benefit from screening for temperature disturbances. As shown inFIG. 50, a guard 606 is standing by an infrared detector camera 608 forsensing thermal radiation from the BTT area and preferably including acard slot 610 in its housing 612. Although a guard 606 is shown, the BTTThermoScan of the present invention can work in an unguarded entrance.In this embodiment the BTT thermal image 560 works as a key toautomatically open a door 614. Accordingly, employee 616 scan herCompany Identification card in the slot 610 which then prompts the userto look at the camera 608 for capturing the thermal image of the BTTarea. If the temperature of the BTT is within acceptable limits, theprocessor of the ThermoScan 608 is adapted to open the door 614. If theBTT temperature shows fever indicating a possible infection the employeeis directed to a nurse. This will greatly help safety procedures infacilities dealing with food products in which one employee having acontagious disease can contaminate the whole lot of food products.

FIG. 51 is a schematic view of another embodiment of the presentinvention to monitor temperature disturbances during physical activitysuch as sports events, military training, and the like, showing infraredthermal detector 620 sensing thermal radiation 622 from an athlete 624.The infrared thermal detector 620 includes a detector head 626 whichcontains an infrared sensor 628, a digital camera, 630 and a set oflights, red 632, yellow 634 and green 636 indicating the thermal statusof the athlete with the red light 632 indicating temperature that canreduce safety or performance of the athlete, a red light 632 flashingthat indicates temperature outside safe levels, a yellow light 634indicating borderline temperature, a green light 636 indicating safetemperature levels, and a green light 636 flashing indicating optimumthermal status for enhancing performance. The infrared sensor 628detects the thermal radiation 622 and if the red light 632 is activatedthe digital camera 626 takes a picture of the scene to identify thenumber of the athlete at risk for heatstroke or heat illness. Theinfrared detector 620 further includes a processor 638 to process and atransmitter 640 to transmit the signal wired or wirelessly. It isunderstood that a wider field of view can be implemented with multipleBTT signals being acquired simultaneously as shown by BTT radiation froma second athlete 642 being sensed by the infrared detector head 626.

Now referring to FIG. 52A, the BTT ThermoScan of this embodimentpreferably includes a micro solid state infrared detector 650 which ismounted on a visor 652 of a vehicle 654 for sensing thermal radiationfrom the BTT of a driver 656 and of ambient radiation monitored byprocessor 658 mounted in the dashboard of the vehicle to determinewhether the driver 656 is at risk of temperature disturbance(hyperthermia or hypothermia) which hampers mental and physical functionand can lead to accidents. In addition the temperature at the BTT siteof the driver 656 can be used for automated climate control and seattemperature control of vehicle 654. When the image of the BTT siteindicates high body temperature the air conditioner is automaticallyactivated.

FIG. 52B is a representation of an image generated by the detector 650showing the BTT area 660 on a display 662. FIG. 48 is a representationof an illustrative image generated with the infrared imaging system ofthe present invention. FIG. 52B shows a frontal view of the human faceand the BTT area 660 displayed on a screen 662 as well as the otherareas outside the BTT area present in the human face such as forehead664, nose 666, and cheeks 668. Please note that FIG. 1B shows an actualphoto of the geometry of the general entry point of the BTT displayed ona screen and FIG. 4A shows a side view of the human face and of the BTTarea displayed on a screen.

FIG. 53 shows an illustrative method of the present inventionrepresented in a flowchart. It is to be understood that the method maybe accomplished using various signal processing and conditioning withvarious hardware, firmware, and software configurations, so the stepsdescribed herein are by way of illustration only, and not to limit thescope of the invention. The preferred embodiment includes detectingthermal radiation from a source that includes at least a portion of theBTT area (step 670). At step 672 an image from a radiation source thatincludes at least a portion of the BTT area is generated. At step 674the image generated at step 672 is displayed. Step 676 identifiestemperature levels from the image displayed at step 674. Step 678determines whether the temperature identified at step 676 matches atemperature target. The temperature target can be indicative of atemperature disturbance or indicative of the need to change the climatecontrol level of the vehicle. Considering a temperature disturbance, ifyes and there is a match between the detected temperature at the BTT andthe stored target temperature, then an alarm is activated at step 680informing the subject of the temperature disturbance (e.g., fever,hyperthermia, and hypothermia) and processing continues at step 670. Ifthere is no match, step 678 proceeds to the next operation at step 670.

To enhance the image generated by the BTT ThermoScan, the method furtherincludes aligning the BTT area with the field of view of the infrareddetector and by removing eyeglasses during thermal detection of the BTTarea.

FIG. 54A is a perspective view of another preferred embodiment showing aperson 100 wearing a support structure 680 comprised of a patch withsensor 682 positioned on the skin at the end of the tunnel and connectedby a wire 684 to a helmet 686 which contains the decoding and processinghardware 688, transmitter 702 and display unit 704. Exemplary helmetsinclude ones known in the art for the practice of sports, military,firefighters, and the like. Alternatively, as shown in FIG. 54B thesupport structure includes eyewear 700 with a warning light 702 andsensor 710 of eyewear 700 connected by wire 704 to the head mountedgear, such as a helmet 706. Sensor 710 has an arm 708 with a springmechanism 709 for positioning and pressing the sensor 710 against theskin at the BTT area.

Now in reference to FIG. 55, the temperature sensor 710 can be mountedon nose pieces 712 of masks 714, for example a mask for firefighters.Wire 716 from mask 714 is mounted in an insulated manner, such as beingpositioned within the structure of mask 714 and air tube 718 thatconnects mask 714 to air pack 722. Wire 716 connects sensor 710 to radiotransmitter 720 located in the air pack 722. Alternatively, wire 716 canbe mounted external to the air tube 718. A warning light 724 in the mask714 alerts the firefighter about high or low temperature.

FIG. 56A is a diagram showing a BTT entry point detection system, whichcorresponds to the area with the highest temperature in the surface ofthe body, including temperature sensor 730, amplifier 732, processor734, and pager 736. Processor 734 is adapted to drive the pager 736 toemit a high frequency tone for a high temperature and a low frequencytone for a low temperature. Scanning of the BTT area with the sensor 730allows precise localization of the main entry point of the BTT, whichcorresponds to the highest frequency tone generated during the scanning.Another preferred embodiment for detection of the main entry point ofthe BTT includes replacing a buzzer or pager emitting sound or vibrationby a light warning system. Exemplarily, FIG. 56B shows a pen 740, a LED738 mounted on a board 746 and a LED 739 mounted on said pen 740, asensor 750, and a processor 742. Wire 744 connects the pen 740 to board746. The processor 742 is adapted to activate light 738, 739, whenduring scanning the BTT area, the highest temperature is found. By wayof example, as shown in FIG. 56B, this pen 740 can be mounted on a board746 next to a shelf 748 where TempAlert thermometers 752 are sold,allowing a customer to precisely locate the main entry point of the BTT.Sensor 750 of pen 740 can be for example a non-contact sensor (e.g.,Thermopile) or a contact sensor (e.g., Thermistor).

The detection of the main entry point of the BTT can also be doneautomatically. Accordingly, FIG. 57 shows a 4 by 4 sensor array 760placed at the BTT. The sensor array 760 contains 16 temperature sensors,which measure the temperature at the BTT site. Each temperature sensorT1 to T16 in the array 760 provides a temperature output. Sensor array760 is connected to microprocessor 754 which is adapted to identify thesensor in sensor array 760 with the highest temperature output, whichcorresponds to the main entry point of the tunnel. For exampletemperature sensor T6 761 is identified as providing the highesttemperature output, then the temperature of sensor T6 is displayed. Theprocessor 754 continually searches for the highest temperature output ofsensor array 760 in an automated manner and the highest temperature iscontinuously displayed.

FIG. 58A is an alternative embodiment showing support structure 758comprised of a piece of silicone molded to fit the BTT area with saidsupport structure 758 containing wire 769 and sensor 770 in itsstructure. FIG. 58B shows the support structure 758 with sensor 770positioned at the BTT area 775 with wire 769 exiting the molded piece ofsilicone structure 758 toward the forehead 773. Now referring to FIG.58C, support structure 758 can alternatively include a multilayerstructure comprised of a Mylar surface 762, sensor 770 with wire 769,and silicone piece 774 in the shape of a cup that encapsulates sensor770, allowing proper and stable positioning of sensor 770 at the BTTarea.

It is also an object of the invention to provide methods and devices fortreating and/or preventing temperature disturbances. As shown in FIG. 2Bthe brain is completely insulated on all sides with the exception at theentrance of the BTT. The BTT is a thermal energy tunnel in which thermalenergy can flow in a bidirectional manner and therefore heat can beremoved from the brain or delivered to the brain by externally placing adevice at the entrance of the BTT that either delivers heat or removesheat. Accordingly, FIG. 59 shows the bidirectional flow of thermalenergy represented by arrows 780 carrying heat to the brain and arrow782 removing heat from the brain with the distribution of heat to andfrom the brain 784 occurring via the thermal storage area 786, with saidthermal storage area shown in FIG. 2B in the center of the brain. Fromthe thermal storage area 786 the thermal energy represented as hot orcold blood is distributed throughout the brain tissue 784 by the bloodvessels 788, for treating and/or preventing hyperthermia (heatstroke) orhypothermia.

Accordingly, another object of this invention is to provide a new andnovel BTT thermal pad for the application of cold or heat to the BTTarea for cooling or heating the brain.

A further object of this invention is to provide a new and novel BTTthermal pad which covers the entrance of the BTT area, which may extendto other areas of the face. However, since the brain is insulated on allother sides but at the BTT entrance, the cooling is only external anddoes not reach the brain, which could be at “frying” temperature despitethe external cooling sensation. Considering that, a preferred embodimentincludes an extended BTT thermal pad covering the face in which only theBTT area is exposed to the cold and the remainder of the extended BTTthermal pad covering the face is insulated, preventing the warming up ofthe gel or ice placed inside the bag. The BTT thermal pad container caninclude a radiant heat-reflecting film over various portions thereof,and an insulator over the same or other portions and which togetherfacilitate directional cooling. Thus, only heat conducted by the BTT isabsorbed as the BTT is cooled.

The BTT thermal device applied to the BTT area promotes selective braincooling or selective brain heating for treating hyperthermia andhypothermia respectively. The brain, which is the most sensitive organto thermally induced damage, can be protected by applying heat via theBTT during hypothermia or removing heat during hyperthermia. The coolingor heating is selective since the temperature of the remaining body maynot need to be changed, this is particularly important when cooling thebrain for treating patients with stroke or any brain damage. Themajority of the brain tissue is water and the removal or application ofheat necessary to cool or heat the brain can be precisely calculatedusing well known formulas based on BTU (British thermal unit). A BTU isthe amount of energy needed to raise the temperature of a pound of water1 degree F., when a pound of water cools 1 F, it releases 1 BTU.

The BTT thermal pad for therapeutic treatment of excessive heat orexcessive cold in the brain preferably includes a bag having asubstantially comma, banana, or boomerang shape, with said bag incomplete overlying relationship with the entire entrance of the BTT,said bag including an outer wall and an inner wall defining a sealedcavity to be filled with ice, gel-like material, solid material, and thelike, for cooling or heating the BTT skin area overlying the entrance ofthe BTT.

An exemplary brain cooling or brain heating device includes hot and coldpad or pack adapted to fit and match the special geometry of theentrance of the BTT and comprising a preferably flexible and sealed padand a gel within said pad, said gel being comprised of a mixture ofwater, a freezing point depressant selected from the group consisting ofpropylene glycol, glycerine, and mixtures thereof associated with othercompounds such as sodium polyacrylate, benzoate of soda,hydroxibenzoate, and mixtures thereof and a thickening agent. Any othercooling or heating device or chemical compounds and gels including acombination of ammonium nitrate and water can be used as cooling agentas well as heating agents such as a combination of iron powder, water,activated carbon, vermiculite, salt and Purge natural mineral powder.Those compounds are commercially available from many vendors (e.g.,trade name ACE from Becton-Dickson).

FIG. 60A shows a diagrammatic view of a preferred dual BTT thermal padalso referred to herein as BTT cold/hot pack 790 located next to eye798, 802 including a dual bag system 792, 794 for both the right andleft sides connected by connector 796. FIG. 60B shows in more detail aperspective view of the single bag BTT cold/hot pack device 810,represented by a device to be applied to the left-side, comprisingpreferably a generally comma-shape, boomerang-shape or banana-shape padwhich is sealed in a conventional fashion at its ends 812 to enclose aquantity of a gel-like material 800 which fills the pad 814 sufficientlyto enable said pad 814 to be closely conformed to the special topographyof the BTT area in the recess between the eye and nose. FIG. 60C is anopposite perspective view showing an extension 816 that conforms to therecess at the BTT area of pad 814 containing gel 800. The device isreferred to herein as BTT cold/hot pad or BTT cold/hot pack. Still inreference to FIG. 60C, perspective view is shown of the BTT cold/heatpack device and which is shown as being formed in a pillow-likeconfiguration which permits the molding of the BTT cold/heat pack intothe BTT area.

In use the BTT thermal pad would be put into a freezer or other chillingdevice for use as a cold compress or would be put into hot water to beused as a hot compress. The BTT thermal pad preferably comprises a toughflexible envelope of plastic material. The material within the BTTthermal pad is preferably a gel which will maintain its gel-likeconsistency over a wide range of temperatures. There exist many gelswhich can be cooled to freezing and which absorb heat during warmup.There are a number of different types of such gels. Some of them freezesolid, and some are flexible even at 0 degrees F. Cold packs such as afrozen water-alcohol mixture can also be used. Alternatively, a BTTthermal pad includes a bag having inner and outer walls lined interiorlywith plastic which define a cavity to be filled with ice through anopening in the bag. In this instance the bag is preferably sealed with arubber material.

Although flexible plastic is described as a preferred material forcontaining the gel, it is understood that any material or fabric can beused including vinyl, cotton, rayon, rubber, thermoplastic, syntheticpolymers, mixtures of materials, and the like. The size and shape of theBTT pad structure is adapted to fit the special anatomy of the recessbetween eye and nose and for matching the special geometry of theentrance of the BTT.

Any cooling or heating device known in the art can be used in the BTTpad treatment device including hot or cold water flowing through tubesthat are adapted to carry or deliver heat to the BTT area. The tubes canbe mounted in any head gear or the frame of eyeglasses, pumpingmechanisms can be mounted in the head gear or eyeglasses for providing acontinuous flow of water through the tubes. The BTT pad can be connectedto tubes which have connectors for joining to a water temperaturecontrol and circulating unit in the head gear or eyeglasses. Hot or coldliquid is circulated through tubes which are in communication with eachother and which deliver or remove heat from the BTT.

Elastic band or hook and loop fastener can be used for securing the BTTpad in position. Any of the support structures mentioned herein can beused to secure the BTT pad in position including a piece of glue. Forexample, the BTT pad can include a clip like mechanism or the BTTthermal pad can be secured to the frame of eyeglasses. Nose pads ofeyeglasses or modified nose pads of eyeglasses can include cooling orheating devices for delivering or removing heat from the BTT. A BTTthermal pad can include a stick mounted in the pad that can held by handand manually placed in the BTT area, for example held by a player duringa break in the game to reduce the temperature in the brain, or forwarming up the brain of a skier during a winter competition.

An alternative embodiment includes a BTT thermal pad attached to a headgear for supplying water to evaporatively cool the BTT area. In thisinstance the cold water is generated by evaporative cooling in theheadband and forehead and upper portion of a wearer's head.

Any cooling or heating device can be used to cool or heat the BTT areafor selective brain cooling or brain heating, preferably using amoldable device that conforms to the anatomy of the region at theentrance of the BTT, with directional temperature control properties forcooling or heating the skin at the entrance of the BTT. Any of thedevices for heating or overheating or for cooling, including electrical,chips, semiconductor, polymers, and the like known in the art as well asdescribed by Abreu in U.S. Pat. No. 6,120,460; U.S. Pat. No. 6,312,393and U.S. Pat. No. 6,544,193, herein incorporated in their entirety byreference, and other pending applications by Abreu can be adapted insupport structures for positioning at the BTT entrance and used forcooling or heating the brain.

The present invention provides a moldable BTT thermal pad or BTT thermalpack in a packaging arrangement that can provide surfaces of differingthermal conductivities and heat reflecting properties so as to prolongthe useful cooling/heating time thereof. The construction and materialsof the BTT thermal pad or BTT thermal pack permits the molding of itsshape and the retention thereof to the BTT site on the skin between theeye and nose. The materials disclosed herein can remain flexible plasticfor temperatures in the range of −10° C. to 140° C.

Referring to FIG. 61, a frontal view of an alternative embodiment of BTTthermal pack 820 is shown including a bag 822 with gel 800 with said baghaving two parts with the first part 824 positioned at the main portionof BTT 824 and containing the highest amount of gel 800 and a secondpart 826 positioned at the peripheral portion of the BTT and containinga smaller amount of gel.

FIG. 62 shows a cross sectional view of the bag 828 of the BTT thermalpack containing gel 800 with said bag sealed in its ends 832, 834.

It is understood that a ring shape surrounding the eye can also be usedor a shape that includes other parts of the face/forehead as long asthere is conformation and apposition of part of the BTT thermal pack tothe BTT area. The preferred shape and dimension matches the specialgeometry of the BTT area described herein.

FIG. 63A shows a preferred embodiment of the BTT thermal pack 830 in itsrelaxed state that includes a hard upper part 836 made preferably ofhard rubber or plastic attached to a bag 838 made of soft plastic withsaid bag containing gel 800 and being deformable upon external pressure.As depicted in FIG. 63B, the BTT thermal pack 830 is shown with acentrally formed convex shape 842 at the opposite end of hard upper part836 upon compression shown by arrows 844 to conform to the BTT anatomy840 between eye 852 and nose 854 of person 100.

The BTT thermal pack is preferably moldable and the container or bagconstructed with materials that are deformable and otherwise pliableover the temperature range of use so as to conform to the anatomy of theBTT area. A central convex area in the pack allows for intimateinteraction and thermal energy transfer at the entrance of the BTT, butit is to be recognized that the specific shape of the convex area of theBTT cold/heat pack itself can be slightly varied according to the ethnicgroup.

FIG. 64A shows a side cross-sectional view of a head 856 of person 100with BTT thermal pack 850 in a pillow-like configuration located at theBTT site 858. Construction of BTT thermal pack is performed so as tomaintain an intimate apposition to the BTT site. FIG. 64B is a frontalview of BTT hot/cold pack 850 shown in FIG. 64A at the BTT site 858located next to the left eye 862.

FIG. 65 shows a perspective view of a BTT thermal pack 860 that includesa bag 864 containing gel 800 and a rod 866 for manually holding said BTTpack 860 at the BTT site. FIG. 66 shows a frontal view of a dual bag BTTthermal pack 870 with bags 872, 874 connected to a rod 880 by flexiblewires 876, 878.

FIG. 67A shows a BTT thermal mask 880 with openings 884 for the eyes and886 for the nose and comprised of a pouch containing gel 800, andincluding bags 888, 890 for matching the anatomy of the BTT area. Theremainder of the mask 880 comprises flat area 892. The flat area 892 ispreferably insulated for allowing directional thermal energy flow, sothe gel 800 only touches the skin at the BTT area. FIG. 67B is across-sectional side view of mask 880 showing pouch 894 with bags 888,890 and the remaining flat area 892.

FIG. 67C is a schematic view of BTT thermal mask 898 with pouches 895,896 which allow intimate apposition to the BTT area being worn by user897.

FIG. 68A is a perspective view showing the BTT thermal pack 900 beingapplied to the BTT area by support structure comprised of eyewear 902being worn by user 903. FIG. 68B is a perspective frontal view of a BTThot/cold pack 930 with dual bags 932, 934 for right and left BTT andconnected by an arm 936 working as a clip to secure a hot/cold pack inplace on the BTT of user 938.

The brain cooling or brain heating device in accordance with theprinciples of the invention includes hot and cold pad or pack adapted tofit and match the special geometry of the entrance of the BTT andcomprising a preferably flexible and sealed pad and a gel within saidpad, with the surface touching the skin having a substantially convexshape. Accordingly, FIG. 69A is a perspective side view of BTT thermalpack 910 and bulging substantially convex part 906 which rests againstthe skin and conforms to the anatomy of the BTT. FIG. 69B is aperspective inferior view of BTT hot/cold pack 910 and bulgingsubstantially convex part 906 which rests against the skin and conformsto the anatomy of the BTT. FIG. 69C is a perspective planar view of BTThot/cold pack 910 and substantially flat part 912 which faces theoutside and does not touch the skin. FIG. 69D is a perspective view ofhot/cold pack 910 with gel 909 being applied to the BTT area of user911.

A tube fit to match the special geometry of the BTT site and anatomy ofthe region with circulating water can also be use for selectivelycooling or heating the brain.

The BTT thermal pack can include a bag so as to avoid direct contactwith the skin depending on the chemical compound used, such as heatingagent to prevent any thermal injury to the skin.

It is understood that a combination temperature sensor and BTT cold/heatpack can be implemented and positioned in place using the supportstructures described herein such as eyeglasses and any head mountedgear. The nose pads of eyeglasses can have a combination of a heat flowsensor to determine how fast heat is being pulled. The gradient forinstance across a thin piece of Mylar indicates the direction of heatflow. It is also understood that the right nose pad of the eyeglasseshave a temperature sensor and the left side has the cooling/heatingdevice that applies or removes heat according to the temperaturemeasured on the opposite side.

It is also understood that many variations are evident to one ofordinary skill in the art and are within the scope of the invention. Forinstance, one can place a sensor on the skin at the BTT site andsubsequently place an adhesive tape on top of said sensor to secure thesensor in position at the BTT site. Thus in this embodiment the sensordoes not need to have an adhesive surface nor a support structurepermanently connected to said sensor.

A plurality of hand held devices with non-contact or contact sensors canmeasure the brain temperature at the BTT for single or continuousmeasurement and are referred to herein as Brain Thermometers orBrainTemp devices. Accordingly, FIG. 70 shows an array 1000 of infraredsensors 1002 viewing the BTT entrance 1004 which are mounted in ahousing 1006 containing a lens 1008 to focus the radiation 1010 onsensor array 1000 in a manner such as that the sensor array 1000 viewsonly the skin at the entrance of the BTT 1004 and a microprocessor 1012adapted to select the highest temperature value read by an infraredsensor 1002 in the array 1000 with the highest value being displayed ondisplay 1014. Exemplary infrared sensors for the array 1000 includethermopile, thermocouples, pyroelectric sensors, and the like. Processor1012 processes the signal and displays in display 1014 the highesttemperature value measured by the sensor 1002 in the array 1000. FIG.71A shows another embodiment comprising of a non-contact measuringsystem that includes a housing 1022 containing a single infrared sensor1018 (e.g., thermopile), a lens 1016 to focus the radiation 1010 of theBTT area 1004 into the sensor 1018, a transmitter 1019, and an ambienttemperature sensor 1020 used to adjust the temperature reading accordingto the ambient temperature, and processing 1012 and display means 1014to process the signal and display a temperature value in addition towire 1015 connected to an external module 1017 with said moduleincluding a processor 1013 adapted to further process the signal such asprocessing spectroscopic measurements, chemical measurements, andtemperature measurements with said module 1017 adapted yet to displayand transmit the value calculated by processor 1013 including wirelesstransmission and transmission over a distributed computer network suchas the internet. An alternative for the pen-like systems in accordancewith the invention and in accordance to FIG. 71A, as shown in FIG. 71B,includes a bulging part 1024 with a substantially convex shape at theend 1030 that touches the skin 1026 and matches the concave anatomy ofthe skin 1026 entrance of the BTT 1028. The bulging convex end 1024touching the skin 1026 helps to stretch the skin 1026 and allow betteremissivity of radiation in certain skin conditions, allowing the systemto measure temperature in the skin of the BTT area at optimal conditionsand with any type of skin.

An exemplary lens system for viewing thermal radiation coming from theBTT can include exemplarily 25 sensors for reading at 1 inch from thetip of the sensor to the skin at the BTT entrance and 100 sensor arrayfor reading radiation coming from a distance of 3 inches between skin atthe BTT and sensor tip. Preferably a five degree field of view, and mostpreferably a two to three degree field of view, and yet even a onedegree of field view is used to see the main entry point of the BTT. Thespot size (view area) of the infrared sensor is preferably between 1 and20 mm in diameter and most preferably between 3 and 15 mm in diameterwhich allows the infrared sensor to receive radiation from the BTTentrance area when said sensor is aimed at the BTT entrance area whichcorresponds to the bright spots in FIG. 1A and the red-yellow area inFIG. 1B. It is understood that an infrared device (thermopile) can beplaced at any distance and read the temperature of the BTT entrancearea, as long as the sensor is positioned in a manner to view the BTTentrance area and a lens is used focus the radiation on to thetemperature sensor.

The array is adapted to receive the temperature of the BTT area. Thetemperature signal received is less than the whole face and is not thetemperature of the face, nor the temperature of the forehead. Thetemperature signal comes from the BTT, one particular area of specialgeometry around the medial corner of the eye and medial aspect of theupper eyelid below the eyebrow. This said temperature signal from theBTT can be acquired by contact sensors (e.g., thermistors), non contactsensors (e.g., thermopile), and infrared thermal imaging. This saidtemperature signal can be fed into a processor to act upon an article ofmanufacturing that can remove or transfer heat as shown in FIG. 73. Withsaid article being activated by the temperature level measured at theBTT by a hand held single measuring device, a continuous temperaturemeasuring device, and any of the devices of the present invention. Inaddition, the temperature level signal can activate another device andactivate a function of said device. The temperature level measured bythe hand held devices can be automatically transmitted by wireless orwired transmission means to a receiver.

FIG. 71C shows another embodiment comprising a non-contact measuringsystem that includes a housing 1032 containing a single infrared sensor1034 (e.g., thermopile), a columnar extension 1036 housing a window 1039and cavity 1038 to focus the radiation 1010 of the BTT area 1004 intothe sensor 1034 which is located about 3 cm from the window 1039 ofcolumnar extension 1036 in addition to an amplifier 1040, processingdevice 1042 and display device 1044 to process the signal and displaythe temperature value. The columnar extension may have a widthwisedimension, either as a cylinder, rectangle, or square, of less than 3mm, preferably less than 2.5 mm and most preferably less than 2.0 mm.

A retractable ruler 1046 is mounted in the housing 1032 and the tip ofsaid ruler can rest on the face and used for assuring proper distanceand direction of the housing in relation to the BTT for optimal view ofthe BTT area. It is understood that any measuring and positioning meansfor optimizing view of the BTT by the sensor can be used and are withinthe scope of the present invention. It is understood that anypositioning device to establish a fixed relationship between the sensorand BTT are within the scope of the invention.

FIG. 72 is a schematic view of another embodiment preferably used as asingle measurement by touching the skin at the BTT with a contacttemperature sensor. Accordingly, FIG. 72 shows a pen-like housing 1050with a sensor 1052 (e.g., thermistor) encapsulated by an insulating tip1054 with a substantially convex external shape to conform to the BTTarea and further including wire 1055 connecting sensor 1052 to processor1056, which is in electrical connection to LCD display 1058, LED 1060,and piezoelectric device 1062. In use the sensor 1052 touches the skinat the BTT entrance area 1004 generating a voltage corresponding to thetemperature, which is fed into the processor 1056 which in turnactivates LED 1060 and device 1062 when the highest temperature over thetime of measurement is achieved, and subsequently displays thetemperature in display. The sensor 1052 and encapsulating tip 1054 canbe covered by the disposable cap with a convex external surface thatconforms to the convex tip 1054.

The temperature signal from sensor 1052 can be converted to an audiosignal emitted by the piezoelectric device 1062 with said audiofrequency proportional to the temperature level measured. In additionprocessor 1056 in the housing 1050 is adapted to lock in the highestfrequency audio signal (which represents the highest temperature) whilethe user scans the BTT area. Furthermore, LED 1060 in the housing 1050can be activated when the highest temperature level is reached, and thenthe value is displayed in display 1058.

It is understood that any article of manufacture that transfers heat orremoves heat from the body in a direct or indirect fashion can be usedin accordance with the principles of the invention. Accordingly FIG. 73shows other exemplary embodiments including a sensing device representedby a non-contact sensing device 1070 such a thermopile housed in a handheld device or a contact sensing device 1072 such as a thermistor housedin a patch measuring temperature in the BTT area which are coupled bywires or wireless transmission means shown previously to an article ofmanufacture such as mattress 1078 or a collar 1080 which can alter itsown temperature or the temperature in the vicinity of said articles 1078and 1080. Exemplary embodiments include a mattress 1078 which is adaptedby electrical means to change its temperature in accordance with thesignal received from the temperature sensor 1070 and 1072 measuringtemperature in the BTT area and an article around the neck such as acollar 1080. Articles 1078 and 1080 are provided with a serpentine tube1074 and 1076 respectively, which run cold or hot water for removing ordelivering heat to the body by mattress 1078 or to the neck and head bycollar 1080, with said water system of mattress 1078 having a valve 1082and of collar 1080 having valve 1083 which is controlled by a processor1084 and 1085 respectively. Processor 1084 of mattress 1078 andprocessor 1085 of collar 1080 are adapted to open or close the valve1082 or 1083 based on the temperature level at the BTT measured bysensor 1070 and 1072. The signal of the temperature sensor 1070 and 1072controls the valves 1082 and 1083 that will open to allow cold fluid tofill a mattress when the signal from the sensor 1070 or 1072 indicateshigh body temperature (e.g., temperature equal or higher than 100.5degrees Fahrenheit). Likewise, when the signal from the sensor 1070 or1072 indicates low body temperature (e.g., temperature lower than 96.8degrees Fahrenheit) the signal from said sensors 1070 and 1072 opens thevalve 1082 and 1083 that allows warm fluid to fill the mattress 1078 andcollar 1080. It is understood that any garment, gear, clothing, helmets,head mounted gear, eyewear, hats, and the like can function as anarticle of manufacture in which heat is removed or transferred toachieve thermal comfort of the wearer based on the temperature of theBTT area. It is also understood that any sensor, contact (e.g.,thermistor) or non-contact (e.g., thermopile or thermal image sensingsystem), measuring temperature at the BTT can be used to control anarticle of manufacture removing or transferring heat to a body orphysical matter. It is further understood that the article ofmanufacturing includes infusion lines capable of delivering warm or coldfluid into a vein of a patient in accordance with the temperature at theskin around the medial corner of the eye and eyelid, which correspondsto the entrance of the BTT. Other exemplary articles of manufactureinclude shoes, floor with heating or cooling systems, electricaldraping, in-line fluid warmers, and the like.

In the embodiment in which a contact sensor touching the skin is used,the probe head can be covered with a disposable cap, such as a piece ofpolymer preferably with good thermal conductivity, with the shape of thedisposable cap to match the shape of the various probes in accordancewith the principles and disclosure of the present invention.

In addition to measuring, storing, and transmitting biologicalparameters, the various apparatus of the present invention such aspatches, eyewear, rings, contact lens, and the like include anidentification and historical record acquisition and storage device forstoring the user's identification and historical data preferably using aprogrammable rewritable electronic module in which data can be changed,added, or deleted from the module. The identification and historicaldata alone or in conjunction with the biological data (such as braintemperature and chemical measurements as glucose level and presence ofantibodies) are transmitted preferably by wireless transmission to amonitoring station. Accordingly FIG. 74 shows a schematic view of theapparatus and system for biological monitoring, identification, andhistorical data used by an animal. It is understood that the systemdisclosed is applicable to humans as well as animals.

FIG. 74 is the schematic of a preferred embodiment for four leggedcreatures showing an exemplary comprehensive system that includes: aneye ring transmitter device 1501 with said eye loop or eye ring 1501preferably including antenna 1500, sensor 1502, microprocessing,transmitting and memory module 1504, and power source 1503 with saidring placed on the eye preferably in the periphery of the eye in theeyelid pocket 1516; a collar 1520 with said collar 1520 preferablycontaining power source 1506, microprocessing, transmitting, and memorymodule 1508, and GPS transmission system 1510 coupled by wireless waves1512 to orbiting satellites 1514 and module 1508 in bidirectionalcommunication by wireless waves 1522 to module 1504 of ring 1501 topower ring 1501 and collect data from ring 1501 with said module 1508 incommunication by radio waves 1511 to external radio receiving station1509 and receiving antenna 1513; an externally placed receiver 1518 andantenna 1519 which receives the signal from module 1504 of ring 1501;and an external antenna 1524 located for instance in a feed lotconnected to computer 1526 with said antenna 1524 in bidirectionalcommunication with module 1504 of ring 1501.

Each eye ring 1501 has a unique serial number permanently or temporarilyembedded to identify the animal remotely. A 24 hour temperature log issent at each transmission, most preferably 6-12 times per day. A uniqueone-way statistical broadcast network architecture allows all members ofthe herd to share one frequency and one set of data receivers. Thereceiver is designed to receive temperature telemetry data from anetwork of livestock eye ring telemetry units and forward it to acollection computer for storage, display, and monitoring.

Although various communication and power systems are shown in FIG. 74,it is understood that the system can work with only one apparatus, forinstance ring 1501 sending a signal to receiver 1518 and antenna 1519for further processing and display, or preferably ring 1501 transmittingdata to module 1508 of collar 1520 which working as a booster radiotransmitter transmits the signal to antenna 1513 and remote station 1509for processing, monitoring, and displaying the data.

It is understood that besides an active system with a battery working asthe power source, a passive system in which the ring 1501 is powered byan external source such as electromagnetic induction provided by collar1520 or antenna 1524 can be used. It is further understood that a hybridsystem that includes both a power source comprised of battery 1503 and apassive system in module 1504 can be used in which module 1504 containsan antenna for receiving electromagnetic energy from module 1508 ofcollar 1520. In this embodiment the active part of the system using thememory in module 1504 powered by battery 1503 collects data from asensor 1502 (e.g., thermistor) and stores the data in a memory chip inmodule 1504. The passive system containing antenna in module 1504 can bealso activated when the four legged creature passes by a couplingantenna 1524, such as for instance an antenna placed in feed lots. Afterthere is a coupling between the passive system 1504 in the ring 1501 andthe external antenna 1524 in the feedlot, the data stored in the memorychip of module 1504 of the ring 1501 is received by the external antenna1524 and transferred to a second memory chip 1523 that is part of themodule external antenna 1524. The processor of module 1504 in the ring1501 is adapted to transfer the stored data any time that there is acoupling with the external antenna 1524. A variety of inductive couplingschemes previously mentioned can be used for powering and collectingdata from eye ring 1501 by antenna 1523 and 1509.

The data from a plurality of mammals (e.g., cattle) is transmitted to areceiving system. Preferably only one animal transmits at a specifictime (equivalent to having only one animal in the system) to avoid datacollisions in the form of interference that prevents successful wirelesstransmission of the biological parameters. Two exemplary schemes can beused, polling and broadcast. The polling approach requires each animalto be equipped with a receiver which receives an individual serialnumber request for data from a central location and triggers thatanimal's transmitter to send the data log. The other approach is abroadcast system, whereby each animal independently broadcasts its datalog. The problem is to avoid collisions, that is, more than one animaltransmitting at a time, which could prevent successful data transfer.Each animal transmitter will preferably transmit at a certain time andthe receiver is adapted to receive the signal from each animal at atime.

The ring 1501 can yet include a solar battery arranged to capture sunlight, digital transmission 16 bit ID# to identify the animal and trackthe animal throughout life. Preferred dimensions for outer diameter ofring 1501 for use in livestock are between 40 and 45 mm, preferablybetween 35 and 40 mm, and most preferably between 30 and 35 mm or lessthan 30 mm. For large animals such as an elephant, such as to detectmoment of ovulation for artificial insemination and birth in captivity,the preferred outer diameter is between 90 and 100 mm, preferablybetween 75 and 90 mm, and most preferably between 50 and 75 mm or lessthan 50 mm. Preferred largest dimension of ring including circuit boardand battery for livestock is between 15 and 20 mm, preferably between 10and 15 mm, and most preferably less than 10 mm, and for large animals afactor of 10 to 15 mm is added to achieve optimal dimensions. Thepreferred height of the ring 1501 for livestock is between 9 and 12 mm,preferably 6 and 9 mm, and most preferably less than 5 mm, and for largeanimals a factor of 5 mm is added to achieve optimal dimensions. Thepreferred embodiment includes hardware disposed in one quadrant of thering which contains the sensor and is located in the inferior eyelidpocket.

An alarm is activated when certain pre-set temperature limits arereached. The system of the invention can also be used with temperaturebeing transmitted in real time for detecting the moment of heat inanimals, which starts when the body temperature of the animal starts torise. The method includes detection of heat, and then inseminating theanimals preferably between 6 to 12 hours after initial detection ofheat, and most preferably between 4 and 8 hours after heat detection.

Preferably the temperature data stored over time (e.g., 24 hours) bymodule 1504 or 1508 is then downloaded to a computer system such ascomputer 1526 adapted to identify thermal signatures. Thermal signaturesare representations of the temperature changes occurring over time andthat reflect a particular biological condition. Exemplary thermalsignatures are depicted in FIGS. 75A to 75E. FIG. 75A is arepresentation of a viral infection in which there is a relatively rapidincrease in temperature, in this example there is a high temperaturewhich corresponds to a pox virus infection such as foot and mouthdisease. On the other hand a slow increase in temperature over 6 to 8hours can indicate a thermal signature for hyperthermia due to hotweather, as shown in FIG. 75B. FIG. 75C shows a rapid increase intemperature reflecting bacterial infection, with spikes followed bysustained high temperature. FIG. 75D shows a thermal signaturereflecting mastitis with a double hump in which there is an initialincrease in temperature followed by a higher increase after the firstepisode. FIG. 75E shows a thermal signature indicating heat (arrow 1544)of animals, in which there is a gradual but progressive increase of thebasal temperature. About 8 to 12 hours from beginning of heat there is afurther increase in temperature indicating the moment of ovulation(arrow 1546), with a further sustained increase in temperature in thepost-ovulation period. It is understood that a digital library ofthermal signatures can be stored and used to identify the type ofbiological condition present based on the signal received from the ringor any other sensor measuring temperature at the BTT, for both humansand animals. The thermal signature acquired by the temperature measuringsystem is matched by a processing system to a thermal signature storedin the memory of a computer and associated software for matching andrecognition of said thermal signatures. It is understood that thethermal signatures system of the present invention includes anytemperature measuring system for both animals or humans in which atemperature disturbance is present, low or high temperature.

A plurality of antenna reception scheme can be used. FIG. 76A shows anexemplary antenna schemes arrangement 1538 including 8 antennas numbered1 to 8 in a pen which can be used to cover a herd of 1000 to 2000animals. At a particular time T1 animal 1530 transmits the data which iscaptured by the closest antenna, for instance antenna 1532. For animaluse and to preserve power the data can be stored for 24 hours and whenthe animal goes by one of the antennas at time T1 the data isdownloaded. When there is fever or a change in biological parameter thetransmitting ring transmits the data continuously. Otherwise the ringonly transmits data once a day. The antenna scheme also can be used as alocator of the animal. The pen and antenna scheme is plotted in acomputer screen and depicted on the screen, and by identifying theantennas receiving the signal the animal can be located with thelocation highlighted in the computer screen. In FIG. 76A antennas 1534and 1532 are receiving the signal whereas antenna 1536 is not receivingthe signal since antenna 1536 is distant from the animal. Thereforeanimal 1530 is located in the area covered by antenna 1532 and 1534.FIG. 76B shows the precise location using a radio receiver directionfinder, in which a radio receiver 1540 is carried by a farmer or locatedin the vicinity of the area covered by antennas 1532 and 1534 whichcontains animal with fever 1530 as well as healthy animals 1542 a, 1542b, 1542 c. Since animal 1530 is the only one emitting signalcontinuously, radio receiver 1540 can precisely identify sick animal1530 among healthy animals. The ID of animal 1530 is transmitted inconjunction with the biological data for further identification ofanimal 1530. Alternatively, a farmer uses an electromagnetic hand heldexternal power switch next to the animal to activate the circuit in theeye ring 1501 in order to manually initiate transmission of data to areceiver for further processing. Any lost animal could also be locatedwith the present invention and an animal which ran from the pen could beidentified as not emitting a signal within the pen.

Although a multiple antenna scheme is shown in FIG. 76A, the preferredembodiment includes an antenna 1513 or alternatively antenna 1519, and aweatherproof metal cased receiver unit with radio receiver module,computer interface, and power source such as receiver 1509 oralternatively receiver 1518.

When using a rewritable or programmable identification serial number,the eye ring 1501 can be reused and a new serial identification numberprogrammed and written for said eye loop or eye ring 1501.

Although a ring in the eyelid pocket is shown, it is understood thatanother method and device includes a temperature signal coming from theBTT of cattle external to the eye which is located in the anteriorcorner of the eye (corner of the eye in animals is located in the mostfrontal part of the eye) with said signal being captured by contact ornon contact temperature sensors as well as thermal imaging.

The signal from eye ring 1501 can preferably automatically activateanother device. By way of illustration, a sprinkler system can beadapted to be activated by a radio signal from eye ring 1501 with saidsprinkler system spraying cold water and cooling off the animal when ahigh body temperature signal is transmitted by eye ring 1501.

A variety of diseases can be monitored and detected by the apparatus ofthe invention. By way of illustration, a characteristic increase inbrain temperature can detect foot-and-mouth disease, babesiosis,botulism, rabies, brucellosis, and any other disorder characterized bychanges in temperature as well as detection of disorders by chemical andphysical evaluation such as detection of prions in the eyelid or eyesurface of an infected animal using antibodies against such prions andcreating an identifiable label such as fluorescence or by generating amechanical or electrical signal at the time of antigen-antibodyinteraction. Prions can cause bovine spongiform encephalopathy knownalso as “mad cow” disease and such prions can be present in the eye andcan be detected by using an immobilized antibody contained in the eyering against such prion or a product of such prion. By detectingmastitis (or an animal with fever) which is scheduled for milking, thepresent invention provides a method to prevent contaminating otheranimals being milked by generating a sequence for milking in which theanimal with fever is milked last. This will avoid contaminatingequipment with a sick animal and with said equipment being sequentiallyused in other healthy animals.

The present invention provides continuous monitoring of animals 24 hoursa day from birth to slaughter with automatic analysis and detection ofany disease that can cause a threat to human health or animal health,besides identification and location of the sick animal. Therefore withthe present invention an animal with disease would not reach theconsumer's table. The present invention therefore includes a method toincrease food safety and to increase the value of the meat beingconsumed. The system of continuous disease monitoring is called DM24/7(disease monitoring 24/7) and includes monitoring the biologicalvariable 24 hours seven days a week from birth to slaughter, feeding theinformation into a computer system and recording that information. Anymeat coming from an animal monitored with DM24/7 receives a seal called“Monitored Meat”. This seal implies that the animal was monitoredthroughout life for the presence of infectious diseases. Any user buying“Monitored Meat” can log on the internet, and after entering the number(ID) of the meat which can be found in the package of the meat beingpurchased. Said user can have access to the thermal life and biologicalmonitoring of the animal and for the presence of fever or disease of theanimal which the meat was derived from. The method and device includes avideo stream associated with the ID of the animal with said video orpictures showing the farm and information on the farm where the animalcame from or the meat pack facility where the animal was processed,providing therefore a complete set of information about the animal andconditions in which such animal was raised. Besides viewing over theinternet, at a private location such as at home, the system may alsoprovide information at the point of sale. Accordingly, whenever the userpurchases the product and a bar code for the product for instance isscanned, a video or photos of the farm or the company packing the meatappear on a screen at the point of sale. This method can be used whenpurchasing any other product and preferably allows the consumer to useidle time in the cashier's station to become more familiar with theproduct purchased.

Preferably the ring has a temperature sensor covered by insulatingmaterial (eg. polyurethane) in one end and with an exposed surface atthe other end. The preferred measuring method uses the measuring surfacefacing the outer part of the anatomy of the eye pocket and theinsulating part facing the inner part of the eyelid pocket.

The eye ring contains memory means for storing on a permanent ortemporary basis a unique identification number that identifies theanimal being monitored. The ID code in the processor of the ring istransmitted to a receiver as an individual number only foridentification and tracking purposes or associated with a temperaturevalue or other biological variable value. The memory chip in the ringcan also contain the life history of the animal and historical dataincluding weight, vaccines, birth date, birth location, gender,diseases, genetic make up, and the like.

Range of the entrance of BTT area is about 30 square cm and the generalmain entry point is 25 square cm and encompasses the medial corner ofthe eye and the area of the eyelid adjacent to the eyelid margin. Thecorrelation coefficient between temperature at the BTT area and the coretemperature reflecting the thermal status of the brain is 0.9. Insteadof using the whole face, the method for infrared or thermal imagingsensing as well as contact sensor includes a temperature signal whichcomes specifically from the BTT area, and the hottest spot in BTT areais then located and used as a source signal to activate another deviceor to deploy an action.

It is understood that an infrared thermal imaging camera can also beused and the point source emitting the highest amount of radiation fromthe entrance of the BTT is selected by the processor in the camera andthe temperature level corresponding to the point source with highestthermal energy is displayed in the display. Exemplary infrared camerasinclude the BTT Thermoscan of the present invention.

The BTT Thermoscan of the present invention is adapted to view theentrance of the BTT around the medial corner of the eye, with the viewof the sensor, by way of a lens, matching the entrance of the BTT areadisplayed in FIGS. 1A and 1B, and in FIGS. 3A to 9. Exemplaryoperational flow for measuring the temperature at the BTT with a thermalimaging system includes the first step of viewing the entrance of theBTT by radiation detector in the camera and a processor adapted to,after the first step, to search for the point source in the thermalimage of the BTT with the highest emission of thermal radiation. In thefollowing step the temperature of the point source in the thermal imageof the BTT with the highest amount of radiation is calculated, with saidcalculated temperature value preferably displayed. In the next step, thecalculated temperature value is transmitted by wire or wireless means toan article of manufacture that can remove heat or transfer heat to thebody in a direct or indirect manner. In the following step, thetemperature of the article of manufacture is adjusted in accordance withthe signal received. Exemplary articles of manufacture that transfer orremove heat from the body in an indirect manner includes the airconditioner/heater systems of vehicles. Exemplary articles ofmanufacture that transfer or removes heat from the body in a directmanner includes vehicle seats. The measuring system in accordance withthe present invention is adapted to seek for the hottest area around thecorner of the eye and eyelid. Once the hottest spot around the medialcorner of the eye and eyelid is found, a second step includes findingthe hottest spot in the area identified in the first step, which meansto find the hottest spot on the entrance of the BTT as shown in FIGS. 1Aand 1B.

Now in accordance with another preferred embodiment of the presentinvention shown in FIG. 77A to 77C, an apparatus comprised of a patchfor use in biological monitoring according to the invention comprisestwo parts: a durable part containing the sensor, electronics, and powersource and a disposable part void of any hardware with said two partsdurable and disposable being detachably coupled to each other preferablyby a hook and loop fastener material (commercially available under thetrade name VELCRO). Accordingly FIG. 77A is a schematic view showing apatch composed of two parts connected to each other by a hook and looparrangement herein referred as VELCRO Patch with said VELCRO Patch 1591including a disposable piece 1730 and durable piece 1596 with saiddurable piece 1596 housing and electrically connecting sensor 1590,power source 1594, and transmitter and processor module 1592 with VELCROsurface 1598 of durable piece 1596 detachably coupled to VELCRO surfaceof disposable piece 1730 and the external surface of said disposablepiece 1730 covered by a liner 1732 which when peeled off exposes anadhesive surface which is applied to the skin. When in use the two parts1730 and 1596 are connected and held in place by the hook and loopmaterial, and liner 1732 is removed to expose the adhesive covering theexternal surface of disposable piece 1730 with said adhesive surfacebeing applied to the skin in order to secure said VELCRO Patch 1591 tosaid skin with sensor 1590 resting adjacent to the entrance of the BTTto produce a signal representing by way of illustration the braintemperature. Although VELCRO hook and loop fastener was described as apreferred attachment between disposable and durable parts, it isunderstood that any other attachment device such as a disposable pieceattached to a durable piece by means of glue, pins, and the like can beused or any other conventional fastening device.

FIG. 77B shows the two parts of a VELCRO Patch comprised of a disposablepart 1600 which contains only VELCRO material and a durable part 1596which contains sensor 1590, power source 1594, module 1592 whichincludes a transmitter, processor, piezoelectric piece, buzzer, andspeaker, transmitter and processor module 1592, and LED 1602electrically connected by wires contained in the VELCRO material withVELCRO surface 1598 of durable piece 1596 detachably coupled to VELCROsurface 1601 of disposable piece 1600 and the external surface of saiddisposable piece 1600 covered by a liner 1604 located on the oppositeside of loop surface 1601 of disposable piece 1600 which when peeled offexposes an adhesive surface which is applied to the skin. Since thehardware housed in the durable part 1596 is relatively expensive saiddurable part 1596 with hardware is reusable while the disposable part1600 can be made relatively inexpensively since it only comprises VELCROloops and since said part is the part in contact with the skin said part1600 may be disposed of after contacting the skin or when it iscontaminated by body fluids. It is understood that the durable part caninclude a flexible plastic housing containing hardware and a disposablepart comprised of a double coated adhesive tape. It is within the scopeof the present invention to include a support structure such as a patchcomprised of two parts in which a disposable part is in contact with theskin and a durable part housing hardware and electrical circuitry is notin contact with the skin. It is yet within the scope of the invention toinclude a support structure comprised of hook and loop material such asVELCRO comprised of two parts one disposable and durable part in whichthe disposable part is in contact with the skin and the durable partcontaining pieces in addition to the VELCRO material is durable and doesnot contact the skin. By way of illustration, but not by limitation, thedurable part of the VELCRO can contain a spring load rod plate such asfound in airway dilators (trade name BreatheRight for humans and Flairfor animals) and the disposable part contains a release liner andadhesive surface which goes in contact with the skin of a human oranimal. Another illustration includes a durable part housing a containerwith fluid or chemicals to be applied to the skin and disposable partwhich goes in contact with the skin by means of an adhesive surface ormechanical fasteners such as elastic bands. Yet another illustrationincludes a watch attached to a VELCRO material working as the durablepart which contains, for instance, a sensing part for measuring glucoseand a disposable part. Preferably the VELCRO part containing the hookswork as the durable part and houses pieces other than the VELCROmaterial while the Velcro part containing the loops work as thedisposable part which preferably is in contact with the body part suchas the skin.

When applied to the skin the VELCRO Patch works as one piece withdurable and disposable parts connected by the hook and loop material andno hardware is visible on the surface of the durable part with theexception of a reporting device such as a LED to alert the user when thebiological parameters are out of range. Accordingly FIG. 77C is aschematic view showing the VELCRO Patch of FIG. 77B, with said VELCROPatch 1724 applied to the skin around the eyes 1726 and with an externalsurface of durable part 1722 containing LED 1720 which is activated byprocessor and driver module (not shown) housed in the durable part 1722of VELCRO Patch 1724.

VELCRO Patch of the present invention can further include attachmentstructure for attaching lenses to said VELCRO Patch, herein referred asVELCRO Eyewear. Accordingly FIG. 78 is a schematic view of VELCROEyewear 1710 comprised of the durable part 1712 which houses sensor1700, power source 1706 and transmitter-processor module 1704 inaddition to groove 1708 adapted to receive lens 1702 which can slide inand be secured at groove 1708. The groove mechanism of the inventionallows for any type of lens to be used and replaced as needed. Howeverit is understood that a permanent attachment of the lens 1702 to theVELCRO durable part 1712 can be used. It is also understood that theVELCRO material can be made in a way to conform to the anatomy of theface and that a variety of fastening devices previously described forattaching the lens can be used. The VELCRO Eyewear can yet have templesattached to its side for further securing to the face of the user. It isalso understood that any sensor can be used including temperature,pressure, piezoelectric sensors for detecting pulse of a blood vessel,glucose sensor, and the like.

FIG. 79A is a perspective view showing another exemplary embodiment of asupport structure 1740 comprised of a bowl-like structure with asubstantially external convex surface 1742 to conform to the anatomy ofthe BTT entrance with said support structure 1740 housing sensor 1744and electrical connection. FIG. 79B shows another embodiment of asupport structure 1748 with a substantially convex outer surface 1750 toconform to the anatomy of the BTT with structure 1748 being alsosubstantially elongated to match the geometry of the BTT entrance andfurther housing sensor 1752 and electrical connection 1754.

FIG. 80 is a cross sectional diagram of a bowl shown in FIG. 79Aincluding a holder 1756 in the shape of a bowl with an external convexsurface 1757 and a sensor 1758 protruding through the surface of thebowl holder 1756 with said sensor being in close apposition to the skin1759 at the BTT and its terminal blood vessel 1755.

FIG. 81A is a schematic top view of another preferred embodiment for thesupport structure comprised of a boomerang or banana shape patch 1760comprised of a thin insulating polyurethane layer 1766 housing a supportstructure 1762 which houses sensor 1764 with support structure 1762having a different height than layer 1766 which makes sensor 1764 toprotrude and be in higher position in relation to layer 1766. Surface oflayer 1766 contains a pressure sensitive acrylic adhesive for securingsaid patch to the skin. FIG. 81B is a schematic side view of boomerangshape patch 1760 of FIG. 81A showing the different height betweenstructure 1762, which houses sensor 1764 and wire 1765, and adhesivepolyurethane layer 1766. The preferred height difference between thestructures 1766 and 1762 is 5 mm, and preferably between 3 and 4 mm, andmost preferably between 1 and 3 mm. FIG. 81C is a perspective view ofpatch 1760 with a release liner on the sensor area 1768 and a releaseliner 1773 comprised of two pieces, a superior piece 1769 and aninferior piece 1771. FIG. 81C shows the superior piece 1769 being peeledoff to expose adhesive surface 1770. The release liner 1773 can comprisea single section or have a single or multiple slits to make a multiplesection release liner. Suitable release liners for use with an adhesivelayer are known in the art. According to this embodiment, when applyingpatch 1760 to the BTT area, sensor liner piece 1768 can be removed firstand patch 1760 is then positioned with the sensor area aligned with theentrance of the BTT. Once the proper final position of the patch 1760 isdetermined, inferior piece liner 1771 is removed and patch 1760 appliedto the nose area, and then superior piece liner 1769 can be removed andapplied to the skin above the eyelid margin. FIG. 81D is a perspectiveview showing patch 1760 being applied to the skin of user 1770 withexternal markings on patch 1760 indicating sensor position 1768 and line1772 for aligning with the corner of the eye. It is understood that thepresent invention includes a sensor arrangement within a supportstructure in which said sensor is located at a different height than thebasic larger support structure comprising the patch.

FIG. 82 is a schematic top view of eyewear showing an exemplaryelectrical arrangement for support structure comprised of modified nosepads and frame of eyewear with said frame of eyewear 1880 includingelectromagnetic switch 1774 in left lens rim 1776 and magnetic rod 1778in left temple 1882 for electrically turning the system on when inelectrical contact, transmitter and power source module 1884 in nosebridge 1886 is electrically connected by wire 1888 in lens rim 1776 toswitch 1774, and antenna 1890 in right lens rim 1892 connected to module1884. When the temples are opened for using the eyewear an electricalconnection is established between switch 1774 and magnetic rod 1778which automatically activates the system. It is understood that avariety of spring mechanisms can be integrated into a shaft holding thesensors for better apposition of said sensors to the BTT area.

The present invention provides a method for optimizing fluid intake toachieve dehydration and avoid dehydration and overhydration. The presentinvention provides a continuous noninvasive core temperature monitoring,and when the temperature reaches certain pre-set levels such asincreased temperature which reflects increased heat stored in the body,then by ingesting fluid the temperature can be lowered. Braintemperature reflects the hydration status and dehydration leads to anincrease in the core (brain) temperature. The method in accordance withthe present invention includes an algorithm for use in the situation ofdehydrated, sedentary people exposed to heat (as illustrated by theexcess mortality during heat waves), and people during physicalactivities. The invention showed that ingestion of 4 ounces of waterevery hour after body temperature reaches 100.4 degrees F. will lowerthe body temperature to 98.6 degrees F. and will keep the bodytemperature at lower than 99.5 degrees F. thus preventing the dangers ofheat stroke. In case of athletes in athletic activities such as cycling,the invention showed that ingestion with fluid containing carbohydratesand minerals (e.g., trade name PowerAde of the Coca-Cola Company) cankeep peak performance with ingestion of 6 to 8 ounces when thetemperature at the BTT reaches 99.3 degrees Fahrenheit and performanceis maintained with ingestion every 1 to 2 hours. A variety of algorithmsfor use in the situation of athletes at risk of overheating, can becreated based on the principle of the invention. Special size containersfor fluid or water can be used by an athlete who is aware of the fluidintake needed during a competition.

A method and algorithm to couple temperature (hypothermia) tonourishment (malnutrition) in elderly and in anorexia nervosa can becreated, with the temperature level indicating malnutrition and furtherindicating what food to ingest to maintain adequate temperature. It isfurther understood that foods can be developed based on body temperatureto achieve optimal nutritional value—fresh and frozen, or processedfoods. It is yet understood that temperature changes indicatingovulation can be used as a method to create foods that increasefertility by identifying what food articles increase ovulation.

The present invention also provides methods and devices for evaluatingdiet such as caloric restriction in which the temperature indicates themetabolism and therefore a lower basal temperature indicates reducedmetabolism and metabolic waste products including monitoringcarbohydrate intake and metabolism. The present invention also providesmethods for monitoring hypoglycemia in diabetes in which lowering of thetemperature is a predictor of a hypoglycemic event. The invention alsoprovides methods for detecting pulmonary infarction and cardiac eventswhich are associated with a particular increase in temperature. Anycondition which is associated with a change in temperature can bepredicted and detected by the present invention from pregnancy disorderscoupled to hypothermia to hyperthermia in head trauma.

The present invention provides a variety of other benefits. Otherexemplary benefits include: 1. monitoring Multiple Sclerosis sinceincrease in brain temperature can lead to worsening of the condition,and a corrective measure can be taken when the present inventionidentifies such increase in temperature, such as by drinking coldliquids at the appropriate time or cooling off the brain as previouslydescribed, 2. significant differences between left and right BTT canindicate a pathological central nervous system condition, 3. detectingincreased brain temperature to reinforce diagnosis of meningitis orencephalitis and thus avoid excess use of lumbar tap in people withoutthe infection, and 4. Young babies cannot regulate their bodytemperature in the same way that adults do and can easily become toohot. Sudden Infant Death Syndrome (SIDS) is more common in babies whohave become overheated. By monitoring babies' temperature the presentinvention can alert parents in case the baby's temperature increases.

A receiver receiving signal from the sensor system of the presentinvention can be external or implantable. When implantable inside thebody the receiver can be powered by magnetic induction externally orbatteries recharged externally. The receiver receives the signal from atemperature sensor, glucose sensor, or the like and retransmits thesignals for further display.

Any transmitter of the present invention can be integrated withBluetooth, GRPS data transmission, and the like. The signal from thetransmitter then can be captured by any Bluetooth enabled device such ascell phones, electronic organizers, computers, and the like. Software ofthe cell phone can be modified to receive the coded signal from atransmitter. Algorithm in the receiver will decrepit the signal anddisplay the value. A cell phone can have an auto dial to call a doctorfor example when fever is noted. It is understood that the signal from acell phone or a signal directly from the transmitter of the supportstructure can be transmitted to a computer connected to the internet forfurther transmission over a distributed computer network.

The prior art used facial skin temperature as detecting means formonitoring body temperature. As seen in FIGS. 1A and 1B, temperature ofthe skin on the face varies significantly from area to area and is notrepresentative of the core temperature. In addition facial skintemperature does not deliver thermal energy in a stable fashion. Anydevice or method that uses facial skin temperature to activate anotherdevice or monitor temperature of the body will not provide a precise noraccurate response. In addition facial skin temperature does notrepresent the thermal status of the body and has a poor correlation withcore and brain temperature. The only skin surface of the body which isin direct and undisturbed communication with inside the body is thespecialized area of special geometry located at the entrance of the BTT.Any temperature sensing device placed on or adjacent to the BTT entrancecan measure core temperature in a precise and accurate manner. It isunderstood that any sensor including a colorimetric sticker such as withliquid crystal colorimetric thermometers can be used and placed on theskin at the entrance of the BTT area, and are within the scope of theinvention.

Now referring to the previously described automated climate controlsystem, an exemplary embodiment will be described in more detail.Although this exemplary preferred embodiment will be described forclimate control in the cabin of a transportation vehicle (e.g., car) itis understood that the method, device and system can apply to anyconfined environment such as home, work place, a hotel room, and thelike in which the temperature inside the confined environment isadjusted based on the temperature at the BTT for achieving thermalcomfort for the subject inside the confined environment.

The temperature measurement at the BTT represents the thermal comfort ofthe body. Investigation by the present invention showed that the thermalcomfort of the body is reduced as the temperature of the body increasesor decreases reflected by a change in brain temperature at the BTT.Thermal comfort of a human being is reflected by the skin temperature atthe BTT, with higher skin temperature at the BTT generating a hot bodysensation while a lower skin temperature at the BTT generates a coldbody sensation. In order to achieve thermal comfort for the occupants ofa cabin the system of the invention manages cabin thermal comfort fromthe temperature signal generated at the BTT. The present inventionpreferably uses a particular specialized area in the face, and not thewhole face to manage the cabin temperature and cabin thermal comfort.The present invention system preferably monitors temperature in lessthan the whole face which causes an optimal control of the heating andcooling of the cabin to achieve thermal comfort of the occupant of thecabin.

Since thermal comfort is reflected in the brain temperature adjustingthe climate cabin based on the temperature of the BTT will provide athermally comfortable environment for the occupant of the cabin. The BTTtemperature is set for controlling the HVAC (heater-air conditioner) andother parts of the vehicle previously mentioned such as seats, carpets,and the like, which are adjusted to maintain the occupant's thermalsensation in a comfortable state. In particular, articles in contact oradjacent to the body are used to automatically remove or apply heat tothe occupant's body based on the BTT signal. To further improve thermalcomfort, the system includes a temperature sensor in the cabin fordetecting cabin temperature. Accordingly, FIG. 83 shows an exemplaryautomated climate control system which includes BTT temperature sensingdevice 1894 for contact measurements (e.g., eyewear) and 1895 fornon-contact measurements (e.g., infrared detector) for monitoringtemperature at the BTT, control device 1896 adapted to automaticallyadjust articles 1898 in the cabin 1900 for removing or delivering heatbased on the signal generated by BTT sensing device 1894, a cabintemperature sensor 1902 to detect the temperature in the cabin 1900, andan article 1898 inside the cabin adapted to remove heat when the signalfrom BTT sensor 1894 indicates high temperature or to deliver heat whenthe BTT sensor 1894 indicates low temperature. Although for illustrationpurposes a vehicle seat will be used as an article forremoving/delivering heat, it is understood that other articles such asHVAC, carpet, steering wheel, and other articles previously mentionedcan be used. As soon as the vehicle is started, the cabin sensor 1902detects the cabin temperature and adjusts the article 1898 for removingor delivering heat based on the temperature signal from the cabin sensor1902. Next or simultaneous with measurement of cabin temperature bysensor 1902, the output of BTT sensor 1894 is fed into control device1896 which activates article 1898 to remove or deliver heat based on thesignal from the BTT sensor 1894. If the BTT sensor 1894 indicates HIGH(>98.8° F.) then article 1898 will remove heat, and if LOW (<97.5° F.)is detected by BTT sensor 1894 then article 1898 will deliver heat, inorder to achieve cabin thermal comfort. An exemplary embodiment forcooling includes control means 1896 connected to an air-conditioningcontrol system for managing the amount of cool air being generated andblown in a proportional manner according to the temperature level outputby BTT sensor 1894. For heating exemplarily the control device 1896 canbe connected to a control system 1906 which gradually adjusts heatdelivery by an electrically-based vehicle seat 1898 according to theoutput level by BTT sensor 1894. Control device 1896 is adapted toremain neutral and not to adjust article 1898 when temperature at theBTT is within 97.5° F. and 98.8° F. Since thermal comfort can vary fromperson to person, the system can be adapted for removing or deliveringheat according to specific temperature thresholds in accordance with theoccupant's individual needs, and not necessarily in accordance todefaults set at 97.5° F. and 98.8° F. It is understood that acombination of skin sensors placed in other parts of the body can beused in conjunction with BTT sensor 1894. It is yet understood that therate of change in the skin temperature can be accounted for and fed intomicrocontroller which is adapted to adjust articles based on a largevariation of skin temperature at the BTT site, with for instance asudden cooling of the body of more than 0.6 degrees generating acorresponding decrease in the amount of cool air being generated or evenshutting off an air conditioner system. It is also understood that BTTsensing devices include contact device (e.g., patches and eyewear of thepresent invention), non-contact devices (e.g., infrared devices of thepresent invention), thermal imaging (e.g., BTT Thermoscan of the presentinvention), and the like.

Yet another embodiment according to the present invention includes asupport structure containing a sensor to measure biological parametersconnected to a nasal strip for dilating airways of humans such asBreathe Right (commercially available under the trade name BreatheRight)and for dilating airway passages of animals (commercially availableunder the trade name Flair). Exemplary air dilator nasal strips weredescribed in U.S. Pat. Nos. 5,533,503 and 5,913,873. The presentinvention incorporates airway dilators into patches for biologicalmonitoring. The present invention can be an integral part of an airwaydilator. The airway dilators can be an extension of the presentinvention. The coupling of a patch measuring biological parameters andan air dilator is convenient and beneficial since both are useful in thesame activities. Nasal airway dilators are beneficial during sleeping,in athletic activities, or when suffering from a cold or respiratoryinfections and the patch of the present invention is used duringsleeping, monitoring temperature changes in athletic activities, andmonitoring fever during respiratory infections. Both nasal airwaydilators and the patch of the present invention use an adhesive in itsbacking to secure to the skin and both are secured to the skin over thenasal bones, the patch of BTT located in the superior aspect of thenasal bone and the air dilator preferably in the inferior aspect of thenasal bone. The nasal airway dilator extension of the patch of thepresent invention is referred to herein as BioMonitor Dilator (BMD).Accordingly, FIG. 84 is a front perspective view of a preferredembodiment showing a person 100 wearing a BMD 1908 including a supportstructure comprised of a patch 109 connected by connecting arm 1907 toair dilator nasal strip 1909 with said BMD placed on the nose 1911 withpatch 109 containing indicator lines 111 and containing an active sensor102 positioned on the skin at the end of the tunnel on the upper part ofthe nose 1911 and air dilator nasal strip 1909 positioned on the skin ofthe lower part of the nose 1911 of user 100. The embodiment of the BMD1908 shown in FIG. 84 provides transmitting device 104, processingdevice 106, AD converter 107 and sensing device 102 connected byflexible circuit 110 to power source 108 housed in patch 109. Although aconnecting arm is shown it is understood that the BMD can be made as onepiece in which the upper part houses the sensor and circuitry and thepart on the lower aspect of the nose includes a spring loaded strip toact as nasal airway dilator. The present invention discloses a method ofsimultaneous monitoring biological parameters while dilating nasalairways.

Another embodiment includes a plurality of kits shown in FIGS. 85A to85D. Accordingly, FIG. 85A is a schematic view of a kit 1910 containingan adhesive tape 1912 and a free sensor 1914 attached to a wire 1916.The free sensor 1914 is unattached to a support structure and when inuse said sensor is preferably placed in contact with the adhesive 1912in order for the sensor 1914 to be secured to the skin by the adhesivesurface of adhesive 1912. Another embodiment shown in FIG. 85B includesa kit 1918 containing a support structure 1920 such as a patch, clip,eyewear (e.g., eyeglasses, sunglasses, goggles, and safety glasses) andthe like, and receiver 1922 illustrated as a watch, but also cell phone,electronic organizer, and the like can be used as a receiver and beingpart of the kit. Kit 1918 can also house a magnet 1923 in its structurewhich acts as a switch, as previously described. It is understood thatkit 1918 can include only a patch with the magnet 1923 adjacent to saidpatch 1922. The watch 1922 preferably has a slanted surface for betterviewing during athletic activities such as during cycling with the fieldof view of the watch 1926 directed at an angle toward the face of thecyclist, so just by looking down and without turning the head the usercan see the temperature level displayed on the watch 1926. A furtherembodiment shown in FIG. 85C includes a kit 1932 containing specializedBMD patch 1928 and a receiver 1930 illustrated as a watch.

Another embodiment includes shoes with temperature sensor for detectingcold and with a radio transmitter to transmit the signal to a receiver(e.g., Watch). The signal from the shoe in conjunction with the signalfrom the TempAlert at the BTT provides a combination of preventivedevice against both frostbite and hypothermia.

It is understood that the support structure such as a patch may housevapors and when the outer surface of the patch is scratched mentholatedvapors can be released to help soothe and relieve nasal congestion,which can be convenient when monitoring fevers with the patch.

It is also understood that steel or cooper can be placed on top of asensor to increase thermal conductivity as well as any otherconventional means to increase heat transfer to a sensor.

It is understood that any electrochemical sensor, thermoelectric sensor,acoustic sensor, piezoelectric sensor, optical sensor, and the like canbe supported by the support structure for measuring biologicalparameters in accordance with the principles of the invention. It isunderstood that sensors using amperometric, potentiometric,conductometric, gravimetric, impedimetric, and fluorescent systems, andthe like can be used in the apparatus of the invention for themeasurement of biological parameters. It is also understood that otherforms for biosensing can be used such as changes in ionic conductance,enthalpy, and mass as well as immunobiointeractions and the like. It isalso understood that new materials and thermally conductive liquidcrystal polymers that produce a response in accordance to temperaturecan be used in the invention and positioned at the BTT site.

The foregoing description should be considered as illustrative only ofthe principles of the invention. Since numerous modifications andchanges will readily occur to those skilled in the art, it is notdesired to limit the invention to the exact construction and operationshown and described, and, accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of theinvention.

1.-46. (canceled)
 47. A measuring system for placement on the skin at anend of a brain tunnel and transmitting a signal to a remote receiver,said measuring system comprising a housing including a portion forplacement between an eyebrow and an eye of a subject on the skin at theend of the brain tunnel, a sensor positioned in the housing forgenerating a signal based upon measurements of said skin at the end ofthe brain tunnel, said housing including a wireless transmitter fortransmitting the signal from said sensor, and a receiver for said signaltransmitted by said wireless transmitter, said receiver including atleast one of a watch, a cellular phone, a computer, an internetappliance and a pager.
 48. The measuring system as claimed in claim 47,wherein a distance from an outer edge of said housing to an outer edgeof said sensor is equal to or less than 11 mm.
 49. The measuring systemas claimed in claim 48, wherein the distance is equal to or less than 6mm.
 50. The measuring system as claimed in claim 49, wherein thedistance is equal to or less than 3 mm.
 51. The measuring system asclaimed in claim 47, wherein said housing includes at least one of apatch, a clip, a medial canthal pad of eyeglasses, a modified nose padof eyeglasses and head mounted gear.
 52. The measuring system as claimedin claim 51, wherein said patch measures less than 11 mm at its greatestdimension.
 53. The measuring system as claimed in claim 47, wherein saidhousing includes a power source.
 54. The measuring system as claimed inclaim 47, wherein said housing includes a microprocessor.
 55. Themeasuring system as claimed in claim 47, wherein said wirelesstransmitter transmits said signal by at least one of a radio frequency,light, sound and electromagnetic energy.
 56. The measuring system asclaimed in claim 47, wherein said wireless transmitter reports thesignal by at least one of a visual, audio and tactile transmission. 57.The measuring system as claimed in claim 47, further comprising a localreporting device in said housing for local reporting of the signal. 58.The measuring system as claimed in claim 47, wherein said sensor is anactive sensor.
 59. The measuring system as claimed in claim 47, whereinsaid sensor measures temperature.
 60. The measuring system as claimed inclaim 47, wherein said sensor measures glucose levels.
 61. The measuringsystem as claimed in claim 47, wherein said sensor measures oxygenlevels.
 62. The measuring system as claimed in claim 47, wherein saidsensor measures electrolyte levels.
 63. The measuring system as claimedin claim 47, wherein said sensor measures pulse.
 64. The measuringsystem as claimed in claim 47, wherein said sensor measures bloodpressure.
 65. The measuring system as claimed in claim 47, wherein saidinternet appliance receives said signal and controls at least one of amedical device, exercise equipment, a bicycle, clothing, footwear, aclimate control system, an electric blanket, a vehicle seat, furniture,sports equipment and military gear.
 66. The measuring system as claimedin claim 47, further comprising a wired transmitter connected by a wirefrom said housing to a display unit.